DePuy ASR™ Hip Recall Resource Packet

Transcription

DePuy ASR™ Hip Recall
Resource Packet
Updated March 1, 2013
For the latest information on the ASR™ Hip Recall,
please visit our website at ASRrecall.DePuy.com
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Table of Contents
I.
Clicking on any
of the following text
will direct you to the
corresponding page
in this publication
Physican Information Overview
5��Summary Guide Click Here
II. Identifying and Notifying Patients
7��Sample Letter to ASR Patients (DPYUS 9 version 2)
8��Sample Letter to Non-ASR Patients (DPYUS 13)
9��ASR Hip System Recall Suggested Talking Points for Office Managers
at Surgeons’ Offices (DPYUS 24 version 2)
Look for additional active
links throughout
for easier navigation.
12��U.S. Patient Medical Authorization Form (DPYUS 11 version 4)
III. Patient Education and Registration of Claims
15��Information for Patients (DPYUS 19 version 2)
20��Patient Handout for Claims and Reimbursement Process (DPYUS 33 version 1)
21��The Broadspire ASR™ Help Line and Reimbursement Program (DPYUS 124 version 1)
IV. Testing and Treatment
23��ASR Hip Patient Treatment Guidelines (DPYUS 25 version 3)
25��Metal Ion, Radiological and Cross-Sectional Testing Protocols (DPYUS 39 version 2)
29��Partial listing of (MARS) MRI centers (DPYUS 131)
35��Whole Blood Collection Recommendation Update (DPYUS 67 version 1)
37�� Phlebotomist Instructions (DPYUS 36 version 2)
38��Quest Diagnostics Blood Test Order Form (DPYUS 68)
39��Surgeon Educational Webcasts Click Here
V. Explants and Revision Reporting
41��ASR Revision Reporting (DPYUS 111)
43��Explant Laboratory Inspection (DPYUS 116)
44��Authorization to Provide ASR Explanted Components to DePuy Orthopaedics, Inc. (DPYUS 114)
45��ASR™ XL Acetabular System/DePuy ASR™ Hip Resurfacing System: Retention of Explanted Components
(DPYUS 108)
46��Court Order: Explant Preservation and Decontamination (DPYUS 109)
VI. Reimbursement for Physician Administrative Time
60��Reimbursement for Administrative Time Associated with Identifying and Notifying ASR Patients
(DPYUS 66 version 1)
VII.Reimbursement for Patients
62��Healthcare Professional Treating ASR Hip System Patients (DPYUS 65 version 2)
65��ASR Product Recall Reporting Form Instructions (DPYUS 41 version 1)
66��ASR Product Recall Reporting Form (DPYUS 42)
VIII.ASR™ Codes
68��ASR Codes (DPYUS 20)
IX.Forms Click Here
Please note: Dates in the footers indicate the last time
that a particular document was updated.
For the latest information on the ASR™ Hip Recall, please visit our website at ASRrecall.DePuy.com
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Contact Information and Additional Resources
DePuy ASR Support Line: 1-866-230-9597
The DePuy ASR Support Line is a key point of contact for information from DePuy on most ASR
recall questions or concerns.
Additional Resources:
• Hospitals:
-- Katie Seppa, Manager of Customer Quality: 1-574-372-7333
• Surgeons:
-- Clinical/scientific questions: U.S./Canada/Latin America:
Rodrigo Diaz, Scientific Information Officer, is available at the ASR Support Line above
-- LabCorp 1-888-LabCorp (1-888-522-2677)
-- Quest Diagnostics 1-800-377-8488
• Explant Retrievals
-- DePuy’s ASR Retrieval Coordinator is available at the ASR Support Line above
• Patients:
-- English-speaking patients and non-English speaking patients in the U.S. and Canada:
To initiate a claim, dial the toll-free ASR Help Line, 1-888-627-2677. This call center will
be active from 8 a.m. to 9 p.m. EST, Monday through Saturday. For other questions or
concerns, call 1-866-230-9597.
Online Resources:
You can find the most updated materials related to the ASR recall on our website at ASRrecall.DePuy.com.
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I.Physician
Information
Overview
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DePuy ASR™ Hip Recall Resource Packet
We appreciate that managing the ASR™ Hip System recall in your practice is a complex undertaking,
and that you, your office staff and your patients have many questions about the management of
ASR patients, as well as the reimbursement process.
• In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new
information from the UK National Joint Registry as part of the company’s ongoing surveillance
of post-market data concerning the ASR Hip System. After reviewing this data, DePuy decided
it was in the best interests of patients to voluntarily recall the ASR Hip System.
• We understand that the ASR Hip System recall is concerning for patients, their family members
and surgeons. Since the recall decision was made, DePuy has worked to provide patients and
surgeons with the information and support they need.
• DePuy is committed to working with patients and their health insurers to address medical costs
directly associated with the recall. DePuy will also address recall-related patient out-of-pocket
expenses, such as co-pays, deductible expenses, lost wages and travel costs. ASR patients
should contact the ASR Help Line at 1-888-627-2677 for assistance.
• All requests for reimbursement of recall-related testing and treatment costs will be reviewed on
a case-by-case basis, regardless of the time elapsed from the date of the initial ASR surgery.
• DePuy’s efforts to support ASR patients and their surgeons remain a top priority. Through
the ASR Help Line, tens of thousands of ASR patients have been assisted; the program for
reimbursing ASR patients for recall-related expenses is well-established; and DePuy has
provided information and support to surgeons who are treating ASR patients. We encourage
ASR patients to visit http://asrrecall.depuy.com and contact the Help Line at 1-888-627-2677
for assistance.
DPYUS 63 (Version 2)
Last updated March 1, 2013
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II.Identifying
and Notifying
Patients
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Sample Letter from Surgeon Offices to ASR Patients
Insert Month, Insert Date, 2011
Dear ______,
I am writing to share important information about your hip replacement implant, the DePuy ASR Hip
System. Some patients with the hip implant you received have experienced problems that require
additional care and potentially further treatment. For this reason, DePuy Orthopaedics, Inc., the
provider of your hip, recalled the ASR Hip System and recommends that patients be evaluated. The
“recall” of the ASR Hip does not necessarily mean you will need to have the hip implant removed.
Please call my office to schedule an appointment for the evaluation of your hip. [Alternative
beginning to this paragraph: For this reason I have scheduled an appointment with you at my office
on insert month and insert date.] During that appointment, I would like to discuss with you any
symptoms/problems you are having, additional testing that has been recommended and the best
plan for ongoing testing and treatment for you.
DePuy is committed to working with patients and their health insurers to address medical costs
directly associated with the recall.
DePuy will also address recall-related patient out-of-pocket expenses, such as co-pays, deductible
expenses, lost wages and travel costs. ASR patients with recall-related out-of-pocket expenses
should contact the ASR Help Line, 1-888-627-2677, for assistance and evaluation of these claims.
The Information for Patients sheet, provided by DePuy, will help to address any questions you
may have about your hip implant, the reason it is being recalled and what you need to do. If you
have any questions regarding the performance of your hip implant, please contact my office. If
you have questions about payment for treatment, please contact DePuy using the phone number
included in the Information for Patients sheet.
Once again, please contact my office as soon as possible to set up a follow up appointment so that I
may address your concerns and discuss the best treatment options for you.
Sincerely,
xx
Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the ASR™ XL Acetabular
System was available worldwide.
DPYUS 9 (Version 4)
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Sample Letter from Surgeon Offices
for Non-ASR Patients
Insert Month, Insert Date, 2011
Dear Patient,
As you may know, one of the providers of hip replacement implants has recalled one type of hip
implant system, the DePuy ASR Hip System. I am writing to inform you that the hip implant I used
in your hip surgery was not from the ASR Hip System. You are not affected by this recall and do not
need to take any additional steps as a result of the ASR Hip System recall.
As always, I encourage you to schedule an appointment with me if you are having a problem with
your hip implant.
Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the
ASR™ XL Acetabular System was available worldwide.
Sincerely,
xx
DPYUS 13 Last updated September 9, 2010
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ASR Hip System Recall Suggested Talking Points
for Office Managers at Surgeons’ Offices
• Thank you for calling.
• I understand your concern about this recall.
• I’m sure you have questions about your hip surgery, including what type of hip implant you
have, and I will gladly answer what questions I can, and, if necessary, schedule an appointment
for you to see Dr. XX.
Information about the Recall
• First, let me provide you with some information about the hip implant being recalled:
-- There are many different brands of hip implants available.
-- The ASR Hip is one of many hip implants available from DePuy Orthopaedics.
-- In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving
new information from the UK National Joint Registry as part of the company’s ongoing
surveillance of post-market data concerning the ASR Hip System. After reviewing this
data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip
System.
-- It is important that ASR patients follow up with their surgeon for evaluation of their hip
implant even if they are not experiencing symptoms.
-- DePuy is committed to working with patients and their health insurers to address medical
costs directly associated with the recall. DePuy will also address recall-related patient outof-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs.
ASR patients with recall-related out-of-pocket expenses should contact the ASR Help Line,
1-888-627-2677, for assistance and evaluation of these claims.
Information about Patient’s Specific Implant
• Now, let’s discuss your specific hip implant.
-- [For surgeons’ offices who will provide information over the phone:] I need some personal
information from you so I may look up your medical records to determine what type of
hip implant you have. Could you give me your full name, date of birth, and social security
number [office managers to insert pertinent information needed for researching medical
records]? Thank you. I need some time to look your medical records up, so please let me
Document ID: DPYUS 24 (Version 2)
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know the best phone number to reach you at later today/tomorrow. Once I have your
medical records, then, either the doctor or I will call you back to discuss what hip implant
you have and whether or not we need to schedule a follow-up appointment.
-- [For surgeons’ offices who do not provide patient information over the phone:]
Due to privacy concerns, I cannot give patient information over the phone. I can tell you
that if you had your hip surgery before July 2003, your hip implant is not a part of this
recall. If your hip surgery was after July 2003, I can schedule an appointment so you may
request your patient information in person.
-- [For surgeons’ offices that are sending letters to hip patients about whether or not
they are impacted by this recall:] Dr. XX is sending/has sent a letter to any patient whose
hip implant is a part of this recall; if you receive/have received one of those letters, then
you will need to schedule a follow-up appointment [office managers to adjust talking point
based on how the office is following up with ASR patients and non-ASR patients].
More Information about Recall
• I want to make sure you know where you can find additional information about the recall or
speak to someone in person.
• If you have an internet connection, DePuy has a special section of its website with recall
information. The address is: http://ASRrecall.depuy.com.
• There’s also a DePuy ASR Support Line to answer your questions, and this toll-free number is:
1-866-230-9597.
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A closer look at the ASR Recall Website
Once you navigate to ASRrecall.DePuy.com click on the appropriate country and language to access
all the information available.
Document ID: DPYUS 122
Last updated October 19, 2011
Authorization to Use or Disclose Information
(Medical Release Form)
I hereby authorize the use or disclosure of my individually-identifiable health information as described below. I
understand this authorization is voluntary. I understand that if the organization or persons authorized to receive the
information is not a health plan or health care provider, then the released information may no longer be protected by
federal privacy regulations.
Patient Name:
Patient Address:
Patient Phone:
Patient Date of Birth:
Persons/organizations providing the information: Doctor Name (Contact): Doctor/Office
Doctor Address:
Doctor Phone:
Doctor Email (optional):
Hospital Name:
Hospital
Hospital Address:
Hospital Phone:
Hospital Email (optional):
Persons/organizations receiving the information:
Broadspire
P.O. Box 608
Berkeley Heights, NJ 07922-0608
phone: (866) 874-2865
fax: (866) 350-0843
Email: [email protected]
I agree that Broadspire may also disclose this information to DePuy Orthopaedics, Inc. and to service providers who are
working under contract to DePuy Orthopaedics, Inc., Broadspire, or their affiliated entities, to assist with the evaluation
and review described in this form.
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Last updated January 17, 2012
Specific description of information to be used or disclosed, including date(s):
1. Copies of all medical records and x-rays of (name)________________________
regarding his/her patient care for the hip implant surgery that occurred on or about
(date)_________________.
2. If surgery was necessary to replace this hip implant (revision surgery), copies of all
medical records and x-rays of the patient named above regarding his/her patient care for
the revision surgery that occurred on or about (date)________________.
These medical records should include but not be limited to new patient intake form,
progress record, telephone message slips, copies of lab work, radiography, consultation
reports, physical therapy reports, product code and lot number of components
implanted; and all records relating to these surgeries and all follow up visits and records.
3. The explanted ASR product component(s), associated hip stem, if applicable, and related
tissue samples, if available.
Reason for use or disclosure of information:
Broadspire, DePuy Orthopaedics, Inc., and their service providers, will use and disclose this information to: (i) evaluate
whether certain costs related to my medical treatment associated with the recall of the ASR Hip product are eligible for
reimbursement and (ii) analyze my experience with the ASR Hip product.
• I understand that I will not be denied health care or health plan coverage, as the case may be,
if I do not sign this form.
• I understand that I may see and copy the information described on this form if I ask for it, and that I get a copy of
this form after I sign it.
• I understand the purpose of this authorization. I have had the opportunity to ask questions about it,
and my questions have been answered to my satisfaction.
• I understand that this authorization will expire one year from date of signature.
• I understand that I may revoke this authorization at any time by notifying the person or organization providing the
information in writing, but if I do, it won’t affect any actions taken before the revocation is received.
• I do not waive my rights to pursue legal action by signing this form
or by disclosing this information
_________________________________________________________ Signature of Patient or Patient’s Representative
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III.Patient
Education
Materials
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Information for Patients
To ASR Hip Replacement Patients:
At DePuy, our mission for more than a century has been developing products and technologies that help patients who
have been impacted by pain, disability and a loss of mobility return to a more active lifestyle. If DePuy finds that one of its
products is not meeting the high standards of our company, our patients, or our surgeons’, we take appropriate action. In
August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National
Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. After
reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System.
Your safety and health are important to DePuy, and we are committed to providing ASR patients with the information
and support they need for their recall-related medical care. It is important that ASR patients follow up with their surgeon
for evaluation of their hip implant even if they are not experiencing symptoms. DePuy is working with patients and their
health insurers to address medical costs directly associated with the recall. DePuy will also address recall-related patient
out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs.
There are many different brands of hip implants available, including several brands from DePuy Orthopaedics, and
patients may not be aware of what brand of implant they have. We encourage patients to check with their surgeon or
hospital to determine what brand of hip implant they have received.
If you have an ASR Hip, please call our ASR Help Line at 1-888-627-2677 to have your specific questions answered and
to begin the claims and reimbursement process. We know that the recall is concerning to patients and their families.
Please visit ASRrecall.DePuy.com for more detailed information. The U.S. FDA also recently provided information on
metal-on-metal hips, such as the ASR Hip System, which can be found here.
If you have additional questions, please do not hesitate to call our ASR Support Line at 1-866-230-9597.
Sincerely,
DePuy Orthopaedics
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Reason for Recall
The ASR Hip System Recall
DePuy’s top priority is and always has been patient safety.
With this priority in mind, we continually evaluate data on
our products.
The ASR Hip System
as shown in the image to the
right, and a metal cap is placed
over the femoral head.
The DePuy ASR Hip Resurfacing
System includes two components:
• A metal cap is placed over the natural femoral head;
and
In a natural hip, the thigh
bone, known as the femur,
is connected to the pelvis at
the hip joint. The femur has
a rounded end, called the
• A one-piece metal cup lines the acetabulum
femoral head. The femoral
head fits like a ball into a
concave surface on the pelvis,
known as the acetabulum. For
this reason, the hip joint is often called a ball and socket
joint. The femoral head rotates within the acetabulum,
which allows for motion. When osteoarthritis, injury or
other conditions cause the hip joint to lose mobility and
become painful, a hip replacement or hip resurfacing
surgery may be performed.
The ASR Hip System is one of many hip implants available
from DePuy Orthopaedics. The ASR Hip System is a onepiece cup and socket that may be used either for total hip
replacement or hip resurfacing.
ASR XL Total Hip Replacement
With an ASR XL total hip replacement, a one-piece metal
component known as an acetabular cup is placed in the
acetabulum as shown in the image below. The femoral
head is replaced with a metal ball which is connected to a
metal stem placed inside the femur.
An ASR XL System includes two components:
• A metal femoral head (or ball) connected to the
stem; and
The ASR Hip Resurfacing System was only approved for use
outside the U.S and was not commercially available in the U.S.
All components for the ASR™ XL Acetabular System and
DePuy ASR™ Hip Resurfacing Platform are part of this recall.
Understanding the Reason for the Recall
At DePuy Orthopaedics, meeting the needs of patients is
at the center of what we do, and everyone at DePuy is
united by the common goal of improving patients’ lives.
DePuy puts patients first. If DePuy finds that a product is
not meeting its high standards and the needs of patients,
we take appropriate action.
In August 2010, DePuy issued a voluntary recall of the
ASR Hip System after receiving new information from
the UK National Joint Registry as part of the company’s
ongoing surveillance of post-market data concerning the
ASR Hip System. After reviewing this data, DePuy decided
it was in the best interests of patients to voluntarily recall
the ASR Hip System.
We understand that the August 2010 ASR Hip System
recall is concerning for patients, their family members
and surgeons. Since the recall decision was made, DePuy
has worked to provide patients and surgeons with the
information and support they need.
• A one-piece metal cup that lines the acetabulum
DePuy ASR Hip Resurfacing System With an ASR Hip
Resurfacing System, a one-piece metal component
known as an acetabular cup is placed in the acetabulum,
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What to Do
The ASR Hip Systems first became available in July
2003. If you had hip surgery prior to July 2003, the hip
you received is not subject to this recall. If you had hip
surgery after July 2003, please contact your orthopaedic
surgeon or the hospital where your surgery took place to
determine whether you received an ASR Hip.
It may take time for the surgeon or hospital to locate this
information for you. For privacy reasons, your orthopaedic
surgeon or the hospital where your surgery took place
may ask you to request this information in person.
Next Steps
If you do not have an ASR Hip:
The hip you received is not subject to this recall. Please
speak to your orthopaedic surgeon about any questions
you may have about your hip replacement.
If you do have an ASR Hip:
• Contact the DePuy ASR Help Line to initiate a claim
with DePuy.
DePuy is committed to working with patients and
their health insurers to address medical costs directly
associated with the recall. DePuy will also address
recall-related patient out-of-pocket expenses, such as
co-pays, deductible expenses, lost wages and travel
costs. ASR patients should contact the ASR Help Line
at 1-888-627-2677 to initiate the claims process.
Learn more about the claims and
reimbursements process on the
“reimbursements” page.
• Schedule an appointment with your surgeon.
If you received the ASR™ XL Acetabular System or
DePuy ASR™ Hip Resurfacing System, your surgeon
will be able to evaluate how your ASR Hip System is
functioning. Additional testing and treatment may
be necessary to evaluate your hip implant.
Follow-up Care
It is important that you follow up with your surgeon, even
if you are not experiencing symptoms, for evaluation of
your hip implant. You should discuss with your surgeon
how frequently you should return for an office visit if you
are not experiencing symptoms.
In some cases, your surgeon may order additional blood
testing or imaging to evaluate your hip. Your surgeon
will determine the best care plan for you and discuss
treatment solutions should they be needed. If you don’t
know who performed your hip replacement surgery, ask
your primary care physician or the hospital where the
surgery took place.
Learn more about Testing on the “Testing” page
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Testing
Diagnostic Testing will help your surgeon evaluate your
hip and determine future treatment recommendations, if
necessary.
• Blood Tests
Your surgeon may order blood testing as part of
your ASR Hip System evaluation. Your surgeon may
recommend a second blood test to confirm the
results of the initial blood test.
What to Expect
Your surgeon may use one or more of several tests to
evaluate your ASR Hip System:
• MRI or Ultrasound
Your surgeon may want to do an MRI or ultrasound
test of your ASR Hip System. Your surgeon may then
recommend additional testing or surgery to replace
your implant.
• X-rays
X-rays will allow your surgeon to evaluate how the
ASR Hip System is positioned, if there is any damage
to the bone, and/or if the ASR Hip System has
remained attached to the bone. If the X-rays show
problems with your ASR Hip System, your surgeon
may recommend surgery to replace it.
Learn more about Claims & Reimbursements on the Reimbursement page.
Treatment
If Revision Surgery Is Necessary
Your surgeon will need to evaluate how your ASR Hip
System is functioning and make a decision on the best
course of treatment for your specific needs.
Learn more about testing and evaluation in the
“Testing” section above.
If Your ASR Hip Is Functioning Well
If you do not have any symptoms or test results that
suggest you may need to have your implant replaced,
then you should follow your surgeon’s recommendations
for continued follow-up.
If you need to have an additional surgery, your surgeon
will select the appropriate implant system for you. The
manufacturer and model of any replacement implant
system is a choice that you and your doctor are best
positioned to make. DePuy is committed to working
with patients and their health insurers to address medical
costs directly associated with the recall. DePuy will also
address recall-related patient out-of-pocket expenses, such
as co-pays, deductible expenses, lost wages and travel
costs. ASR patients should contact the ASR Help Line at
1-888-627-2677 for assistance.
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Claims & Reimbursements
Your safety and health are important to DePuy, and
we are committed to providing ASR patients with the
information and support they need for their recall-related
medical care.
DePuy is working with patients and their health
insurers to address medical costs directly associated
with the recall.
DePuy will also address recall-related patient out-ofpocket expenses, such as co-pays, deductible expenses,
lost wages and travel costs. DePuy has engaged an
independent, third party claims processor, Broadspire,
so that you may be reimbursed quickly and efficiently.
The reimbursement process offers patients the benefit of
highly professional customer support from a specialized
claims-processing company. In order to submit your claim
and receive reimbursement for eligible costs associated
with treatment, you will need to obtain a claim number
by calling the ASR Help Line (1-888-627-2677). When
you call the ASR Help Line, you will be instructed on how
to submit claims for reimbursement.
A Broadspire representative will collect basic patient
information and will provide the patient with a claim
number. Once the claim is initiated, a Broadspire claims
adjustor is assigned as a resource for the patient to address
any questions and/or concerns regarding the recall. Patients
can contact their Broadspire representative at any time for
additional information or to submit expenses.
It is important to note that patients do not waive the
right to pursue legal action by initiating a claim for
reimbursement, signing the Patient Authorization Form or
providing medical information to Broadspire.
Submitting Claims for Reimbursement
Call 1-888-627-2677 to obtain a claim number and to get
instructions on how to submit a claim for reimbursement.
Reimbursement for Out-of-Pocket Expenses
DePuy will address recall-related patient out-of-pocket
expenses, such as co-pays, deductible expenses, lost wages
and travel costs. After you have initiated a claim, please
submit any requests for reimbursement for out-of-pocket
expenses and costs you incur associated with receiving
treatment to our third party claims processor, Broadspire.
Eligible costs for reimbursement may include:
• Medical treatment including testing, treatment, and
revision surgery if required
• Travel and hotel expenses related to treatment
• Lost wages related to missed work associated with
treatment
Claims will be evaluated on a case-by-case basis.
Insured Patients
DePuy is working with many public and private insurers
(including Medicare) to establish a single and simplified
process to address claims for recall-related care and
medical treatment, including revision surgeries. If you
are an ASR patient who requires recall-related diagnostic
testing and medical treatment and you have insurance,
whether through a public or private insurer, please
seek out the medical care that you need and submit
those charges directly to your insurer for coverage as
you normally would. We have provided physicians with
a number of guidelines regarding available test and
monitoring options and we continue to update these
guidelines as new information comes to our attention.
Uninsured Patients
For patients without any insurance or health care
coverage, please contact the ASR Help Line operated by
Broadspire, an independent, third-party claims processor
engaged by DePuy, at 1-888-627-2677 to determine the
options that may be available to you and any of your
treating providers.
Please call the DePuy ASR Support Line at
1-866-230-9597 for answers to any additional questions
you may have.
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Do you have an ASR™ Hip System?
DePuy would like to share important claims
and reimbursement information with you.
Call the ASR Help Line
888-627-2677
If Unsure
You will be asked to
confirm you have an ASR
Implant
If Yes
If you are unsure if you have an ASR implant, please
contact your orthopaedic surgeon or hospital.
If you know that you have an ASR a patient record
(claim) is started.
We will start a patient record (claim) in case you do
have an ASR implant.
You will be contact by a claims representative.
If you confirm you have an ASR implant, please
notify the claims processor.
Definitions
Claim: Patient record started by DePuy’s processor
to track your expenses and documentation.
Letter of payment authorization: Letter that
indicates your out-of-pocket costs should be
submitted for processing to DePuy’s claim processor.
Medical authorization form: Your health
and medical information is private. A medical
authorization form allows surgeons/hospitals
to share your individually-identifiable health
information with DePuy and DePuy’s third-party
claims processor in order to process claims.
The claims representative will send you a letter of
payment authorization, an ASR claim number, and
a medical authorization form for your approval to
share a copy of your medical records. Please note
that signing this form does not waive your rights to
pursue legal action.
We recommend seeing your orthopaedic surgeon
for evaluation/treatment. Please provided your
physician with the letter of payment authorization
to cover eligible out-of-pocket costs
Submit any expenses and documentation to the
claims processor for review for eligibility.
Reimbursements for eligible expenses issued
by the claims processor.
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The Broadspire ASR™ Help Line and Reimbursement Program
To ensure that ASR patient recall-related questions are addressed and out-of-pocket expenses reimbursed as efficiently
as possible, DePuy Orthopaedics, Inc. has engaged Broadspire Services Inc., an independent claims processor, to assist
ASR patients. The reimbursement process offers patients the benefit of highly professional customer support from
a specialized claims-processing company. The Broadspire reimbursement program uses common, well-established
claims processes developed specifically to make it easy for patients and health care providers to initiate claims, submit
information and receive reimbursement.
A process focused on the patient’s needs
DePuy is committed to working with patients and their health insurers to address medical costs directly associated
with the recall of the ASR Hip System. DePuy, through Broadspire, will also address recall-related patient out-of-pocket
expenses, such as co-pays, deductible expenses, lost wages and travel costs. Because Broadspire specializes in the
complex business of processing medical claims, this reimbursement program assists patients and health care providers
with information and recall-related reimbursement professionally, effectively and in a timely fashion.
Using this patient-focused approach, Broadspire has assisted tens of thousands of callers in the U.S. To date, thousands
of payments have been made to cover expenses for testing and treatment, and patient out-of-pocket expenses,
including expenses related to revision surgeries and lost wages for ASR patients.
The process for requesting reimbursement for ASR recall-related expenses is straightforward. First, patients should register
as a claimant by contacting Broadspire. Once confirmation that the patient has received an ASR implant is received from
either the patient or the patient’s health care provider, recall-related expenses can be submitted directly to Broadspire.
How Broadspire assists ASR patients
ASR patients can contact the Broadspire ASR Help Line at 1-888-627-2677 to register a claim.
A Broadspire representative will collect basic patient information and will provide the patient with a claim number. Once
the claim is initiated, a Broadspire claims adjustor is assigned as a resource for the patient to address any questions
and/or concerns regarding the recall. Patients can contact their Broadspire representative at any time for additional
information or to submit expenses.
Patients do not waive the right to pursue legal action by initiating a claim for reimbursement, signing the Patient
Authorization Form or providing medical information to Broadspire.
How Broadspire collaborates with Health Care Providers
Patients’ safety and health is important to DePuy, and DePuy does not want cost to be a barrier to treatment. In order
to minimize patients’ out-of-pocket expenses, physician practices and healthcare facilities can submit co-pays and/or
deductibles for registered patients directly to Broadspire.
In addition, DePuy, through Broadspire, will reimburse physicians, physician practices, and healthcare facilities for
a reasonable amount of time they and their staff spend performing certain administrative activities associated with
identifying and notifying patients about the ASR recall.
Health Care Providers can contact the Broadspire claims department at 1-866-874-2865 for instructions on submitting
patients’ co-pays and deductibles.
Document ID: DPYUS 124 (version 1)
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IV. Testing and
Treatment
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ASR Hip patient treatment guidelines
DePuy’s ASR Recall Guide provides guidelines for testing and treatment of ASR Hip patients. DePuy believes that all patients
with a joint replacement be followed up periodically with a frequency determined by local guidance, relevant physician
clinical protocol, and the needs of individual patients. Since the announcement of the ASR recall, guidelines have been
issued in several markets around the world to provide market-specific guidance. These guidance documents provide
important information for surgeons to consider along with their own medical expertise and the needs of each patient.
Information Resources
This information should be used in conjunction with your normal clinical practice and is not intended to and should not
take the place of your medical judgment or expertise regarding your patients’ treatment.
Food and Drug Administration
Information for Patients Considering
a Metal-on-Metal Hip Implant System
Food and Drug Administration
Information for Surgeons Regarding
a Metal-on-Metal Hip Implant Systems
American Academy of Orthopaedic Surgeons
Questions and Answers
about Metal-on-Metal Implants
2012 Annual Meeting of the American Academy
of Orthopaedic Surgeons: Scientific Exhibit
The Hip Society: Algorithmic Approach
to Diagnosis and Management
of Metal-on-Metal Arthroplasty
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MHRA
Medical Device Alert: All metal-on-metal (MoM)
hip replacements (MDA/2012/008)
MHRA
Metal-on-Metal hip implants resource page
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Metal Ion, Radiological and Cross-Sectional Testing Protocols
On August 24, 2010, DePuy Orthopaedics, Inc. issued
a voluntary recall of all ASR products. Since the recall,
DePuy has received inquiries from surgeons concerning
how to evaluate patients who received an ASR product.
This update is designed to provide information related to
frequently asked questions, and should not preclude any
other routine clinical evaluation or treatment or your own
medical judgment.
We hope this information assists you in the evaluation
and treatment of your ASR patients.
A LabCorp form is included in this publication. Click here.
To find the closest lab please visit: www.labcorp.com.
A Quest Diagnostics form is included in this publication.
Click here.
To find the closest laboratory or Patient Service Center
visit: www.questdiagnostics.com
Radiological Protocol Suggestions
1. X-rays should be obtained on an annual basis or as
per standard of care
Whole Blood Collection Suggestions
At the evaluation visit, if the patient is symptomatic or
if you or the patient has concerns about the hip, blood
metal ion testing (cobalt and chromium in whole blood)
should be considered.
If your office, the insurer, or patient is mistakenly
charged for the metal ion testing, those charges will be
reimbursed by DePuy/Broadspire upon receipt of charges.
Patients should be advised to refrain from taking mineral
supplements, vitamin B-12 or vitamin B complex at least
three days prior to specimen collection.
Results may be reported in different units. Please note the
following are equivalent:
1 ppb = 1 μg/l = 1 ng/ml
2. All efforts should be in place to have consistency
of positioning in each view which could be reliably
used to compare with previous radiographic exams
in order to assess any radiographic changes since
the original procedure.
3. Views for plain x-rays:
a. AP-Pelvis (centered at symphysis pubis)
b. AP-Hip (at hip joint center)
c. Cross table lateral
4. If using digital radiographs, it is recommended to
have the image size at 1:1 to facilitate any linear
dimension analysis.
5. Radiographic signs of interest:
Cobalt and chromium in whole blood will need to be
drawn at a LabCorp Patient Service Center or Quest
Diagnostics Patient Service Center.
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While we encourage you to familiarize yourself with
the available medical literature on the subject, our
current understanding of potential radiographic signs
of interest discussed in the literature is as follows:
• Interface implant-bone demarcations
• Periprosthetic osteolysis lesion(s)
• Femoral neck narrowing (resurfacing)
• Acetabulum inclination angle subtended
by a horizontal reference line delineated by
interobturator line tangent to inferior aspect of both
obturator foramen and a line through the open face
of the acetabulum.
• Hip joint center relative to vertical line through
tear-drop and a horizontal reference line, i.e.,
intraobturator line.
Machine Settings
Machine settings are specific to each MRI scanner. The
manufacturer of the MRI scanner should be contacted
to identify the appropriate settings for the metal artifact
reduction sequence (MARS). The MARS order provided by
the surgeon to radiology should include “MARS fast spin
echo” or “MARS turbo spin echo” to reduce artifacts.
MRI Findings
MRI findings should be correlated with clinical
examination. MRI may demonstrate changes that appear
to correspond to macroscopic surgical findings (soft-tissue
necrosis, abnormal masses, sterile fluid collections and
bone necrosis).
MRI Signs of Interest
• Acetabulum coverage
(superior-lateral and inferior-medial)
current understanding of potential MRI signs of
interest discussed in the literature is as follows:
• Visible changes from previous radiographs
Additional Cross-sectional Imaging Suggestions
Magnetic Resonance Imaging (MRI)
MRIs should be ordered as MRI with metal artifact reduction
sequences (MARS) to reduce the size and intensity of
magnetic field distortion created by the implant
• Periprosthetic soft tissue mass with no hyperintense
T2W fluid signal or fluid-filled peri-prosthetic cavity
• Peri-prosthetic soft tissue mass/fluid-filled cavity or
lesions with either of following:
-- Muscle atrophy (fatty infiltration) or edema in any
muscle other than short external rotators or
Click here for a listing of (MARS) MRI facilities.
Patient Position
Supine, feet first
Position pelvis in the centre of body matrix coil (top of
prosthesis at top of coil)
Landmark at centre of coil
-- Bone marrow edema: hyperintense on short
inversion recovery sequence (STIR)
-- Fluid-filled cavity extending through deep fascia
• Tendon defect and/or avulsion, intermediate T1W
soft tissue cortical or marrow signal
Fluid collections are usually well circumscribed and
best seen on T2-weighted sequences. Cores have signal
intensities similar to that of bladder fluid, while the
pseudocapsules appear hypointense to skeletal muscle
and often feature areas of no signal.
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Soft-tissue masses are more solid and best seen on a T2weighted sequence. They may appear less circumscribed
than the fluid collections and may have no obvious
capsule and can characterize loss of muscle definition and
tissue planes.
Ultrasound
Ultrasound can be used when a MARS MRI is not
available. Ultrasound should be performed by staff
experienced in conducting musculoskeletal ultrasound
scans. Ultrasound findings should be correlated with
clinical examination; these may demonstrate changes that
appear to correspond to macroscopic surgical findings
(soft-tissue swelling, abnormal masses, fluid collections,
muscle or tendon abnormalities and bone necrosis).
Patient Position
Supine and lateral decubitus
Probe Placement
To obtain sagittal oblique images place probe parallel to
long axis of femoral neck.
To obtain additional images, place probe anteriorly,
posteriorly and directly laterally to femoral neck.
Ultrasound Findings
Any abnormality needs to be examined in multiple planes.
Examination includes inspection of the psoas muscle.
Use probes of varying frequency depending on the size
of the patient.
Ultrasound Signs of Interest
current understanding of potential ultrasound signs
of interest discussed in the literature is as follows:
• Extra-articular fluid collection
• Fluid collections (identified as hypoechoic areas in
soft tissues)
• Solid or cystic masses
These suggestions are based on the attached published
literature references. These articles provide more
information related to the MARS MRI and ultrasound
techniques and the findings related to soft tissue
reactions around hip replacements. Medical practice is
constantly evolving, so there may be new suggestions
regarding imaging techniques in the future. Any updated
suggestions or guidances will be found on the DePuy
website, ASRrecall.DePuy.com. If you have additional
questions, please contact DePuy’s Scientific Information
Office at 888-554-2482.
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DePuy Contact Information:
U.S./Canada/Latin America
• Rodrigo Diaz, Scientific Information Officer
1-866-230-9597
References
1.
CT and MRI of hip arthroplasty. J.G. Cahira, A.P. Toms, T.J. Marshall, J. Wimhurst, J. Nolan; Clinical Radiology, 2007; 62:1163-1171.
2.
Optimization of metal artifact reduction (MAR) sequences for MRI of total hip prostheses. A.P. Toms, C. Smith-Bateman, P.N. Malcolm, J. Cahir, M. Graves; Clinical Radiology.
2010; 65:447– 452.
3.
The imaging spectrum of peri-articular inflammatory masses following metal-on-metal hip resurfacing. Christopher. S. J. Fang, Paul Harvie, Christopher L. M. H. Gibbons, Duncan
Whitwell, Nicholas A. Athanasou, Simon Ostlere; Skeletal Radiol. 2008; 37:715–722.
4.
The painful metal-on-metal hip resurfacing; A. J. Hart, S. Sabah, J. Henckel, A. Lewis, J. Cobb, B. Sampson, A. Mitchell, J. A. Skinner J Bone Joint Surg [Br] 2009;91-B:738-44.
5.
“Asymptomatic” Pseudotumors After Metal-on-Metal Hip Resurfacing Arthroplasty Prevalence and Metal Ion Study; Young-Min Kwon, Simon J. Ostlere, Peter McLardy-Smith,
Nicholas A. Athanasou, Harinderjit S. Gill, and David W. Murray, MD; The Journal of Arthroplasty, 2010.
6.
Metal-on-metal hip resurfacings—a radiological perspective; Zhongbo Chen, Hemant Pandit, Adrian Taylor, Harinderjit Gill, David Murray, Simon Ostlere; European Society of
Radiology, 2010.
7.
Grading the severity of soft tissue changes associated with metal-on-metal hip replacements: reliability of an MR grading system. Helen Anderson, Andoni Paul Toms, John G.
Cahir, Richard W. Goodwin, James Wimhurst, John F. Nolan; Skeletal Radiol Published online July 2010.
8.
Magnetic Resonance Imaging Findings in Painful Metal-On-Metal Hips: A Prospective Study. Shiraz A. Sabah, Adam W.M. Mitchell, Johann Henckel, Ann Sandison, John A.
Skinner, and Alister J. Hart, The Journal of Arthroplasty, 2010 [epub ahead of print].
9.
Metal Artifact Reduction Sequence: Early Clinical Applications. Randall V. Olsen, Peter L. Munk, Mark J. Lee, DennisL. Janzen, Alex L. MacKay, Qing-San Xiang, Bassam Masri;
RadioGraphics 2000; 20:699-712
10. Magnetic Resonance Imaging in the Diagnosis and Management of Hip Pain After Total Hip Arthroplasty. H. John Cooper, Amar S. Ranawat, Hollis G. Potter, Li Foong Foo, Shari
T. Jawetz, Chitranjan S. Ranawat; The Journal of Arthroplasty. 2009; (5):661-67.
11. A Consensus Paper on Metal Ions in Metal-on-Metal Hip Arthroplasties. Steven J. MacDonald, Wolfram Brodner, Joshua J. Jacobs; The Journal of Arthroplasty 2004; 19(8) Suppl.
3: 12-16.
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Partial listing of (MARS) MRI centers
For Surgeons who manage the care of ASR™ patients
Attached for your information is a list of some outpatient MRI centers that have experience with Metal
Artifact Reduction Sequence (MARS) MRI capability, which is used in the management of some ASR
patients. DePuy will add to this list as facilities become known to us. Of course no endorsement of these
facilities should be implied or inferred; this list is provided simply for your information. Please let us know if
you would like assistance with locating imaging centers in your area. You can contact the DePuy ASR Support
Line: 1-866-230-9597.
State
Facility
Contact Number
City
Facility Type
Arkansas
Touchstone Open MRI of Hot Springs
501-623-6736
Hot Springs
Independent Outpatient
Arizona
Phoenix Diagnostic Imaging (MedQuest) - Chandler
480-812-1705
Chandler
EVDI Medical Imaging - Chandler
480-456-9000
Chandler
Phoenix Diagnostic Imaging (MedQuest) - Superstition
480-813-8700
Gilbert
EVDI Medical Imaging - East Mesa
480-456-9000
Mesa
Phoenix Diagnostic Imaging (MedQuest) - Dobson
480-964-4995
Mesa
SimonMed - Mesa Baywood
489-264-4900
Mesa
SimonMed - Desert Ridge
480-306-7900
Phoenix
SimonMed - Deer Valley
623-234-2520
Phoenix
Phoenix Diagnostic Imaging (MedQuest) - Ahwatukee
480-753-6161
Phoenix
Desert Valley Radiology - Phoenix North (Bell)
602-867-0404
Phoenix
Desert Valley Radiology - Phoenix Metro
602-395-5089
Phoenix
Desert Valley Radiology - Phoenix West
623-772-6840
Phoenix
Southwest Diagnostic Imaging (Valley Radiologists)
480-425-5000
Scottsdale
SimonMed - Scottsdale
480-614-8555
Scottsdale
Scottsdale Medical Imaging - Scottsdale Medical Center
480-425-5000
Scottsdale
Scottsdale Medical Imaging Desert Mountain Medical Plaza
480-425-5000
Scottsdale
Scottsdale Medical Imaging Thompson Peak Medical Plaza
480-425-5003
Scottsdale
SimonMed - Sun City West
623-214-6609
Sun City West
SimonMed - Surprise Stadium Village
623-302-7900
Surprise
Desert Valley Radiology - Tempe
480-785-2511
Tempe
Radiology LTD Wilmot Diagnostic Imaging
& Treatment Center
520-290-4842
Tucson
Alliance Healthcare Services
520-289-8089
Tucson
Auburn Imaging Center
530-888-8878
Auburn
California
RadNet - Truxtun Downtown
Bakersfield
RadNet - Truxtun Empire
Bakersfield
RadNet - Beverly Tower Wilshire
Beverly Hills
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State
Facility
Contact Number
City
Facility Type
Carmichael Imaging
916-961-4910
Carmichael
RadNet - Concord
Concord
RadNet - Emeryville
Emeryville
RadNet - SFVIR
Encino
Folsom Imaging I
916-984-0739
Folsom
RadNet - Freemont
Freemont
RadNet - Fresno
Fresno
RadNet - Lancaster
Lancaster
RadNet - Los Coyotes
Long Beach
RadNet - Modesto
Modesto
Monterey
Mountain View
Central Coast Diagnostic Radiology (SimonMed)
831-656-9800
RadNet - Mountain View
Newport Imaging Center North
949-574-8200
Newport Beach
Newport Imaging Center South
949-721-8191
Newport Beach
SimonMed - Newport Beach
949-646-4400
Newport Beach
Medical Center Magnetic Imaging (MCMI)
510-869-8777
Oakland
RadNet - Orange Anaheim Gateway
Orange
RadNet - Orange Advanced
Orange
RadNet - DAI Palm Desert
Palm Desert
RadNet - DAI Palm Springs
Palm Springs
RadNet - Pleasanton
Pleasanton
RadNet - Grove
Rancho Cucamonga
RadNet - Rancho Mirage
Rancho Mirage
RadNet - Brewster
Redwood City
RadNet - Northridge
Reseda
RadNet - HCI
Riverside
HealthCare Imaging Center
951-682-7580
Riverside
Roseville Imaging
916-784-2277
Roseville
MRI @ Sutter Roseville Medical Center
916-781-1450
Roseville
29th Street MRI
916-453-9999
Sacramento
MRI Center at Sutter Memorial
916-733-1808
Sacramento
Capitol Imaging
916-453-9999
Sacramento
Fort Sutter MRI/CT
916-733-8755
Sacramento
South Imaging
916-681-8852
Sacramento
RadNet - DRI
Sacramento
Imaging Healthcare
619-295-9729
San Diego
Sharp Rees-Stealy
858-653-6133
San Diego
California Pacific Medical Center and The Imaging Center
415-600-2940
San Francisco
RadNet - RMISF
San Francisco
RadNet - Samaritan
San Jose
RadNet - Montpelier
San Jose
RadNet - Santa Rosa
Santa Rosa
Redwood Regional Medical Group
707-525-4040
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State
Facility
Contact Number
City
Facility Type
RadNet - SVAMI
Simi Valley
RadNet - TVA
Temecula
RadNet - MDI
Thousand Oaks
RadNet - Burbank Advanced
Toluca Lake
RadNet - Valencia
Valencia
RadNet - San Fernando MRI
Van Nuys
RadNet - Ventura
Ventura
RadNet - Elite
Colorado
Delaware
Florida
Idaho
Illinois
Victorville
Denver Integrated Imaging South
720-932-0930
Centennial
Cherry Creek Imaging
303-355-4674
Denver
Denver NMR
303-623-5701
Denver
Health Images at South Denver
305-577-4000
Englewood
Health Images at Cherry Hills
303-762-0060
Englewood
Touchstone Imaging Dry Creek
303-662-1674
Englewood
Fort Collins MRI
970-493-0567
Fort Collins
The Imaging Center at Harmony
970-297-6227
Fort Collins
Touchstone Imaging Lakewood
303-216-9000
Lakewood
Health Images at SouthPark
303-794-8000
Littleton
Touchstone Imaging Highline
720-889-2795
Littleton
Advanced Medical Imaging - McCaslin
303-433-9729
Louisville
Touchstone Imaging Thornton
303-991-2021
Thornton
Orthopedic & Neuro Imaging (ONI)
302-644-7335
Lewes
Papastavros’ Associates Medical Imaging
302-644-2590
Lewes
CNMRI
302-678-8100
Milford
Florida Hospital Celebration Health
407-303-4000
Celebration
Hospital
NeuroSkeletal Imaging (NSI) of Merritt Island
321-454-6335
Merritt Island
Advanced Imaging Center
352-867-7205
Ocala
Florida Hospital Orlando
407-303-5600
Orlando
Hospital
Indian River MRI
772-562-3030
Vero Beach
Diagnostic Health - Weston
954-349-0054
Weston
Boise Radiology Group / St. Luke’s Radiology
208-381-2222
Boise
Hospital
Imaging Center of Idaho
208-454-4965
Caldwell
Pinnacle Imaging Center
208-855-2900
Meridian
Hawthorne Medical Works (3T Imaging)
708-391-8300
Chicago
Advanced Medical Imaging Center - Downtown
312-807-3555
Chicago
MRI Lincoln Imaging Center - Belmont
773-248-7100
Chicago
Advanced Physicians Group
815-836-3788
Crest Hill
Illinois Bone & Joint Institute (IBJI) MRI - Des Plaines
847-954-7600
Des Plaines
Advanced Medical Imaging Center - Merrionette Park
708-377-3730
Merrionette Park
Illinois Bone & Joint Institute (IBJI) MRI - Morton Grove
847-779-6021
Morton Grove
Touchstone Peoria Imaging
309-692-7674
Peoria
Summit Radiology
815-654-2486
Rockford
Rockford Orthopaedic Associates MRI
815-381-7451
Rockford
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State
Facility
Contact Number
City
Facility Type
Springfield Imaging Center (MedQuest)
217-528-4770
Springfield
Springfield Clinic
217-528-7541
Springfield
Bloomington Bone & Joint
812-333-4000
Bloomington
South Bend Orthopaedics
574-247-9441
Mishawaka
Maryland
Johns Hopkins University School of Medicine
410-502-2831
Baltimore
Hospital
Minnesota
Suburban Imaging - Blaine
763-225-6500
Blaine
Center for Diagnostic Imaging - Burnsville
952-898-6627
Burnsville
Center for Diagnostic Imaging - Coon Rapids
763-433-2000
Coon Rapids
Suburban Imaging - Coon Rapids
763-792-1999
Coon Rapids
Center for Diagnostic Imaging - Eden Prairie
952-294-8222
Eden Prairie
St. Paul Radiology - Woodbury
651-739-8147
Lake Elmo
Suburban Imaging - Maple Grove
763-416-7888
Maple Grove
Center for Diagnostic Imaging - Maple Grove
763-416-9916
Maple Grove
Center for Diagnostic Imaging - Maplewood
651-748-8226
Maplewood
Center for Diagnostic Imaging - Mendota Heights
651-455-5500
Mendota Heights
Center for Diagnostic Imaging - St. Louis Park
952-543-6524
St. Louis Park
St. Paul Radiology - Downtown
651-292-2010
St. Paul
St. Paul Radiology - Gallery Towers
651-292-2010
St. Paul
Indiana
Center for Diagnostic Imaging - Woodbury
651-735-1840
Woodbury
Montana
Advanced Medical Imaging
406-556-5200
Bozeman
Hospital Outpatient
Nebraska
Touchstone Village Point Imaging Center
402-502-7226
Omaha
Nevada
Desert Radiologists - Horizon Ridge
702-759-4500
Henderson
Desert Radiologists - Eastern
702-794-2100
Las Vegas
Desert Radiologists - Cathedral Rock
702-759-4333
Las Vegas
Desert Radiologists - Palomino
702-759-8720
Las Vegas
Steinberg Diagnostic Medical Imaging - Southwest
702-732-6000
Las Vegas
Steinberg Diagnostic Medical Imaging - Maryland
702-732-6000
Las Vegas
Steinberg Diagnostic Medical Imaging - Northwest
702-732-6000
Las Vegas
New Hampshire
Dartmouth Hitchcock Medical Center
603-650-4488
Lebanon
Hospital
New York
Medical Arts Radiology
631-665-2261
Bayshore
Hospital for Special Surgery
212-606-1000
New York
631-475-5300
Patchogue
516-822-3600
Plainview
Cooperative Magnetic Imaging (CMI) - St. Luke’s
315-735-7287
Utica
Carolina Imaging Center of Fayetteville
910-483-1321
Fayetteville
Greensboro Imaging - West Wendover
336-433-5000
Greensboro
Institute of Diagnostic Imaging
701-234-0112
Fargo
Sanford Medical Center
701-234-6337
Fargo
Hospital
Aurora Imaging
701-732-2100
Grand Forks
Community MRI Services
701-253-5800
Jamestown
Oregon Advanced Imaging - Navigator’s Landing
541-608-0350
Medford
Grants Pass Imaging & Diagnostic Center
541-472-5154
Grants Pass
MRI of York
717-843-0385
York
North Carolina
North Dakota
Oregon
Pennsylvania
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State
Facility
Contact Number
City
Facility Type
Tennessee
Diagnostic Imaging - Premier Radiology
423-698-5561
Chattanooga
Chattanooga Imaging Hixson
423-553-1234
Hixson
Abercrombie Radiological Consultants
865-588-1397
Knoxville
Touchstone Imaging Arlington
817-472-0801
Arlington
River Ranch Radiology Medical Science Center
512-454-9597
Austin
River Ranch Radiology Post Oak Centre South
512-454-9597
Austin
River Ranch Radiology Round Rock Center
512-454-9597
Austin
River Ranch Radiology Northwest Center
512-454-9597
Austin
Austin Health Imaging
512-451-8595
Austin
ARA (Austin Radiological Association) Austin Center Boulevard
512-795-8505
Austin
ARA (Austin Radiological Association) - Quarry Lake
512-519-3402
Austin
ARA (Austin Radiological Association) - Westlake
512-328-4984
Austin
ARA (Austin Radiological Association) - William Cannon
512-346-7311
Austin
ARA (Austin Radiological Association) - Midtown
512-519-3456
Austin
ARA (Austin Radiological Association) - Southwood
512-428-9090
Austin
ARA (Austin Radiological Association) - Medical Park Tower
512-454-7380
Austin
Austin Diagnostic Clinic Imaging Center
512-901-8729
Austin
ARA (Austin Radiological Association) - Cedar Park
512-485-7199
Cedar Park
Prime Diagnostic Imaging
214-341-8770
Dallas
Touchstone Imaging Denton
940-349-9301
Denton
Touchstone Imaging Oaktree Plaza
940-320-6901
Denton
Touchstone Imaging Flower Mound
972-724-0100
Flower Mound
Pennsylvania Avenue Imaging Center
(Radiology Associates)
817-321-0300
Fort Worth
Touchstone Imaging Fort Worth
817-294-1131
Fort Worth
Touchstone Imaging Fossil Creek
817-428-5002
Fort Worth
Touchstone Imaging Garland
972-495-7756
Garland
ARA (Austin Radiological Association) - Georgetown
512-863-4648
Georgetown
Diagnostic Radiology of Houston - East Sam Houston
713-425-8100
Houston
Diagnostic Radiology of Houston - North Gessner
713-425-8100
Houston
Diagnostic Radiology of Houston - Pine Oak
713-425-8100
Houston
Touchstone Imaging Hurst
817-498-6575
Hurst
Touchstone Imaging Lewisville
972-434-6737
Lewisville
Envision Imaging at Hunters Row
817-453-7444
Mansfield
Touchstone Imaging Mesquite
972-289-5558
Mesquite
Touchstone Imaging Plano
972-378-6858
Plano
Touchstone Imaging Richardson
972-744-0882
Richardson
ARA (Austin Radiological Association) - Rock Creek Plaza
512-238-7195
Round Rock
Preferred Imaging of Round Rock
512-828-3220
Round Rock
Sendero Imaging Medical Center
210-614-8899
San Antonio
Sendero Imaging North Central
210-614-8899
San Antonio
Sendero Imaging South
210-614-8899
San Antonio
Texas
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State
Utah
Virginia
Washington
Facility
Contact Number
City
Facility Type
South Texas Radiology Imaging Center (STRIC) Orthopaedic Imaging Center
210-617-9100
San Antonio
South Texas Radiology Imaging Center (STRIC) Huebner Imaging Center
210-617-9190
San Antonio
Concord Imaging
210-572-2222
San Antonio
ARA (Austin Radiological Association) - San Marcos
512-392-1831
San Marcos
Mountain Medical Imaging
801-713-0600
Murray
Millcreek Imaging Center
801-313-1955
Salt Lake City
Hospital Outpatient
Insight Imaging Center of Arlington
703-820-2775
Arlington
MRI & CT Diagnostics
757-965-4131
Chesapeake
Fairfax MRI Center
703-698-4488
Fairfax
Hospital Outpatient
Chesterfield Imaging Center
804-639-5489
Midlothian
Hospital Outpatient
MRI of Reston
703-478-0922
Reston
Bon Secours West End MRI
804-673-4200
Richmond
Hospital Outpatient
Bon Secours Towne Center MRI
804-594-2550
Richmond
Hospital Outpatient
Insight Imaging - Roanoke
540-581-0882
Roanoke
MRI & CT Diagnostics
757-671-1144
Virginia Beach
Washington Imaging Services
425-688-0100
Bellevue
Valley Radiologists, Inc.
253-661-4737
Renton
Valley Diagnostic Imaging Services
425-656-5550
Renton
Page 6 of 6
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Whole Blood Collection Recommendation Update
This update contains information related to using LabCorp and Quest Diagnostics for Blood Metal Ion Testing. Please
note that a billing account number is only necessary for LabCorp; billing for Quest is associated with the ASR test codes.
If your office, the insurer, or a patient is mistakenly charged for the metal ion testing, these charges will be reimbursed
by DePuy/Broadspire upon receipt of charges.
As previously recommended, patients should be advised to refrain from taking mineral supplements, vitamin B-12 or
vitamin B complex at least three days prior to specimen collection.
Cobalt and chromium in whole blood will need to be drawn at a Patient Service Center either at LabCorp or Quest
Diagnostics or at a physician’s office.
LabCorp
• If referring a patient to LabCorp Patient Service
Center:
-- Complete the requisition form (DPYUS36)
including the following information:
·
·
·
·
·
·
Patient’s name
Patient’s address
Patient’s date of birth
DePuy ASR Claim number
Surgeon’s first and last name
Surgeon’s fax number
(results will be faxed to this number)
· Surgeon’s LabCorp account number
(if available)
· DO NOT ORDER ANY ADDITIONAL TESTING ON
THIS REQUISITION. A separate requisition must be
prepared if the patient has an additional script.
· To find the closest lab please visit:
www.labcorp.com.
• If blood is being drawn at physician’s office or clinic
and sent to LabCorp:
-- Complete LabCorp requisition form (DPYUS36)
·
·
·
·
·
·
Patient’s name
Patient’s address
DePuy ASR Claim number
Surgeon’s fax number (results will be faxed to
this number)
· Surgeon’s LabCorp account number (if
available)
-- Draw two (2) Royal Blue top EDTA tubes and
discard first tube. Assure you discard the first
Royal Blue EDTA tube drawn. Any metal
contaminants from the needle will be contained
in the first tube.
-- Label the remaining Royal Blue top EDTA tube
drawn with patient’s name and date of birth.
-- Refrigerate after collection.
-- Call DePuy’s Scientific Information Office at
(888) 554-2482 to request sample pickup.
-- DO NOT ORDER ANY ADDITIONAL TESTING ON
DPYUS 67 (version 1)
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Quest Diagnostics
• If referring patients to Quest Diagnostics Patient
Service Center:
-- Complete the requisition form (DPYUS68)
·
·
·
·
·
·
·
·
·
DePuy ASR Claim ID/Claim number
Patient’s name
Test Codes for ASR patients only:
95088 Cobalt in whole blood
95089 Chromium in whole blood
95090 Phlebotomy Fee
Surgeon’s fax number (results will be faxed to
this number)
· Surgeon’s account number (if available)
· DO NOT ORDER ANY ADDITIONAL TESTING ON
THIS REQUISITION. A separate requisition must
be prepared if the patient has an additional
script.
-- To find the closest laboratory or Patient Service
Center visit: www.questdiagnostics.com
• If blood is being drawn at physician’s office or clinic
and sent to Quest Diagnostics:
-- Complete Quest requisition form (DPYUS68)
·
·
·
·
·
·
·
·
·
DePuy ASR Claim ID/Claim number
Patient’s name
Test Codes for ASR patients only:
95088 Cobalt in whole blood
95089 Chromium in whole blood
95090 Phlebotomy Fee
Surgeon’s fax number
(results will be faxed to this number)
· Surgeon’s account number (if available)
-- Draw one (1) Royal Blue top EDTA and discard
tube then draw two (2) Royal Blue top EDTA
tubes. Assure you discard the first Royal Blue
EDTA tube drawn. Any metal contaminants from
the needle will be contained in the first tube.
-- Label the remaining two Royal Blue top EDTA
tubes drawn with patient’s name and date of birth.
-- Refrigerate after collection.
-- Call DePuy’s Scientific Information Office at
(888) 554-2482 to request sample pickup.
-- DO NOT ORDER ANY ADDITIONAL TESTING ON
Metal ion Results reporting
Results may be reported in different units. Please note the following are equivalent: 1 ppb = 1 μg/l = 1 ng/ml
DPYUS 67 (version 1)
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Laboratory Corporation of America Holdings PHLEBOTOMIST INSTRUCTIONS: (If you have any questions concerning this request, please contact 1-‐888-‐LabCorp (888-‐522-‐2677). Please enter the following information for the requisition for Depuy Orthopaedics. This order is not to be combined with any other client order and should be sent to the laboratory along with the specimen and the LCM requisition.  Ordering Account: 13103875  The patient case number should be entered in the patient ID field if provided by the physician.  Demographic information on the patient is required (Name, Date of Birth, Address) This order is authorized by: (Enter full name of physician)___________________________________ UPIN ___________________ The ordering physician’s signature must appear on this sheet. Please enter the physician’s name in the physician name field on the LCM order.  Test Ordered: 790480. This is the ONLY test that is authorized for ordering on account 13103875. Specimen requirements: 2 ml whole blood, collect in metal-‐free collection tube, container is Royal Blue-‐top (EDTA) tube. Specimen should be refrigerated for storage and transport.  To ensure the physician receives the results, enter the cc: function and key the physician’s LabCorp account number, or fax number if the physician does not have an account. INSTRUCTIONS FOR SURGEON/PHYSICIAN: Orders for patients who need to receive Chromium and Cobalt testing on whole blood for the Depuy Orthopedics recall should include the following information: Patient First Name:___________________________ Patient Case # (DePuy Code)_____________________ Patient Last Name:___________________________ Ordering Physician Name:_______________________ Patient Gender:_____________________________ Ordering Physician Phone #:______________________ Patient DOB:________________________________ Ordering Physician LabCorp Account # (if LabCorp client):_____________________________ Patient Address:_____________________________ _____________________________ Ordering Physician Fax #:________________________ This order will NOT be processed unless this completed paperwork is presented by the patient to the LabCorp phlebotomist. I, _____________________________________(physician name), authorize Laboratory Corporation of America to send lab results for _________________________(patient name) to DePuy Orthopaedics. My fax number or my LabCorp account number is provided on this order. I understand that it is my obligation to notify DePuy if the patient does not authorize DePuy to have these test results. Signature of Physician: __________________________________ DPYUS 36 (Version 2)
Last updated December 11, 2012
DePuy Account #:
ORDERING PHYSICIAN:
DATE ORDERED
Address:
PATIENT ID # / Claim #
Telephone #:
Fax #:
Client #:
Physician ______________________
NPI/UPIN ______________________
PATIENT NAME
PATIENT DATE OF BIRTH
This order will NOT be processed unless this completed paperwork signed
below is presented by the patient to the Quest Diagnostics phlebotomist.
I, ____________________________________________________________ (physician name),
authorize Quest Diagnostics to send lab results of tests ordered below
for ________________________________________________ (patient name),
to DePuy Orthopaedics.
Signature of Physician: ______________________________________________
95088
95089
95090
TESTING:
DPY Cobalt
DPY Chromium
DPY Phlebotomy Fee
SPECIMEN REQUIREMENTS:
Chromium, Blood
SPECIMEN: Whole blood
VOLUME:
Standard: 2 mL
Minimum: 1 mL
CONTAINER: Royal blue-top (EDTA) in trace element
collection system
SHIP TEMP: Refrigerated
STABILITY:
Refrigerated: 14 Days
Cobalt, Blood
SPECIMEN: Whole blood
VOLUME:
Standard: 4 mL
Minimum: 2 mL
CONTAINER: EDTA (royal blue-top)
SHIP. TEMP: Refrigerated
STABILITY:
Refrigerated: 5 Days
Visit QuestDiagnostics.com to:
• Schedule an appointment (or call 888-277-8772)
• Find Quest Diagnostic locations (or call 800-377-8448)
Walk-in patients are always welcome
Quest, Quest Diagnostics, the associated logo and all associated Quest Diagnostics marks are the trademarks of Quest Diagnostics. Copyright © 2003
Quest Diagnostics Incorporated. All rights reserved. www. All other marks - ®' and ™'- are the property of their respective owner.
SPECIMEN REQUIREMENT SCRIPT. Revised 11/10.
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Surgeon Educational Webcasts
DePuy has hosted educational Webcasts for surgeons who manage the care of ASR patients.
You can access the Webcasts anytime using the links below:
ASR™ Hip System Patient Management Webcast
April 20, 2011
Optimized MRI Webcast
November 18, 2010
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V.Explants
and Revision
Reporting
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ASR Revision Reporting
Thank you for your continuous support throughout the recall of the ASR™ XL Acetabular System and DePuy
ASR™ Hip Resurfacing System. As the recall efforts progress, we would like to ask your assistance with
the reporting of revision surgeries using an online form (link below). This form provides a secure method
of providing the necessary information to continue fulfilling our obligations to the federal government for
medical device reporting (MDR). Please note that the HIPAA Privacy Rule permits disclosing protected health
information, without a patient authorization, to a medical device company, for the purpose of medical device
reporting. You can use this form to report pending or completed revision surgeries.
To notify DePuy of a revision surgery, simply click here, You can access this form at any time on DePuy’s Web
site, ASRrecall.DePuy.com. If you have questions about the process for explanted components, please call the
ASR Retrieval Coordinator at 1-866-230-9597.
Thank you again for your continued assistance with the ASR Recall efforts. We appreciate your support.
DPYUS 111
Last updated May 12, 2011
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Explant Laboratory Inspection
DePuy has retained Orthopaedic Hospital in Los Angeles, a retrieval laboratory under the leadership of
Patricia Campbell, Ph.D., for the receipt, visual inspection and storage of explanted DePuy ASR™ and ASR™ XL
hip system components and related tissue samples. If the patient chooses to provide their explants, DePuy
will provide the appropriate authorization forms, shipping containers, and prepaid shipping labels for the
hospital representative to send the explants to Orthopaedic Hospital.
Please refer questions regarding patient authorization, explant shipping procedures, or explant disposition to
the ASR Retrieval Coordinator at 1.866.230.9597 or via e-mail: [email protected].
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Authorization to Provide ASR Explanted Components
to DePuy Orthopaedics, Inc. and/or
DePuy’s Third Party Retrieval Lab(s)
I hereby authorize my surgeon and/or the Hospital where my revision surgery is occurring (or has occurred) to provide
to DePuy Orthopaedics and/or DePuy’s third party retrieval lab(s) my explanted ASR product component(s), associated
hip stem, if applicable, and related tissue samples, if available, for testing and inspection and storage pursuant to the
Stipulated Preservation Order and Preservation Protocol entered by the Court on April 6, 2011, in MDL No. 2197, In re
DePuy Orthopaedics ASR Hip Implant Product Liability Litigation.
Patient Name: Patient Address: Date of Revision Surgery & Location:
Name of Surgeon
& Contact Info:
Patient Date of Birth:
Persons/organizations providing the information for this Authorization: Doctor/Office/Hospital Name(Contact)/Attorney:
Address: Phone:
Email (optional):
• I understand the purpose of this authorization, have had the opportunity to ask questions about it and my
questions have been answered to my satisfaction.
• I understand that I will not be denied health care or health plan coverage if I choose not to sign this form.
• I understand that I do not have to provide to DePuy and/or DePuy’s third party retrieval lab(s) my explanted ASR
components and/or related tissue samples.
• I understand that I may revoke this authorization at any time, but if I do, it won’t affect any actions taken before a
written revocation is received.
• I understand that this authorization will expire one (1) year from the date of my signature on this authorization.
• I understand that I may see and copy the information described on this form if I ask for it, and that I can get a copy
of this form after I sign it.
• I DO NOT WAIVE MY RIGHTS TO PURSUE LEGAL ACTION BY SIGNING THIS FORM OR BY AGREEING TO THIS
AUTHORIZATION.
_______________________________________________________________
Signature of Patient or Patient’s Representative
DPYUS 114
__________________
Date
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ASR Recall Update:
ASR XL Acetabular System/DePuy ASR Hip Resurfacing System;
Retention and Preservation of Explanted Components
Dear Hospital Representatives and Surgeons:
As you are aware, any medical device implanted into a patient belongs to the patient. In the event of
revision, the patient must make the decision regarding the final disposition of the implant. The patient
may choose to keep the implant, request the hospital to dispose of the implant using hospital standard
procedures or provide the implant to a third party, i.e. DePuy’s designated retrieval laboratory or to the
patient’s counsel. The patient’s written authorization is required for transfer of the implant to a third party.
The Federal Court overseeing ASR litigation which has followed the August 2010 recall of the ASR Hip
Systems has entered an Order requiring that the parties (DePuy Orthopaedics Inc. (Defendant and the
Plaintiffs) make good faith efforts with non-party medical practitioners and hospitals to preserve explanted
ASR Hip System components. Therefore, disposal of explanted systems should only be considered when
specifically directed by the patient and only after contacting the lawyers identified in Section F Page 8 of the
Order.
The parties have also agreed upon a Protocol for the preservation and handling of the explanted
components. This Order and Protocol, which you will find on the following pages, applies only for the
preservation and handling of ASR Hip System components.
Please review, and note that the Protocol for Decontamination and Preservation (Exhibit A) calls for explants
to be decontaminated in accordance with the hospital’s standard procedures unless the patient, or the
patient’s counsel, requests that the explant be handled in a different fashion. Please note that DePuy does
not object to a patient or their lawyer making other arrangements with the patient’s surgeon and/or the
hospital for the fixation or decontamination of the retrieved components so long as the components are
appropriately decontaminated and preserved.
Tissue samples, if taken, are to be fixed according to hospital pathology procedures. Please note that DePuy
does not object to a patient or their lawyer making other arrangements with the patient’s surgeon and/or the
hospital for the fixation of tissue samples in a manner other than in accord with hospital procedures so long
as the tissue samples are appropriately preserved.
While not being requested by DePuy, please note that DePuy has no objection to a patient or patient’s lawyer
making other arrangements for the retention, preservation, and shipping of synovial fluid and whole blood/
serum for an individual patient.
DPYUS 108
Last updated April 6, 2011
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DePuy, and the lawyers for many patients, have retained separate third party retrieval laboratories for the
inspection of explanted ASR devices:
• If the ASR explanted components have been authorized by the patient to be shipped to DePuy’s third
party retrieval laboratory, DePuy will supply packaging, tracking and shipment instructions to you shortly.
This will include explants previously removed and presently in storage at your facility, as well as explants
removed henceforth.
• If a patient or a patient’s lawyer authorizes that their explanted components/tissue samples be shipped
to a different third party retrieval laboratory, that patient or lawyer is responsible for providing packaging
and shipment instructions, and those explants are not to be shipped to DePuy’s retrieval lab at this time.
• Should you have questions about what to do with an individual patient’s explants, or should any dispute
arise with a patient or a patient’s lawyer regarding their explants, the Order provides contact information
(Section F, Page 8) for lawyers who will assist in providing an answer to your questions.
Thank you for your assistance. If you have any questions as to explanted components/tissue samples for
which authorization has been obtained for them to be sent to DePuy’s retrieval laboratory, please contact
DePuy’s Explant Retrieval Coordinator, Lester Pierce, at (866) 230-9597.
Click here to view the court ordered ASR Explant Preservation and Decontamination Protocol
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Case: 1:10-md-02197-DAK Doc #: 127 Filed:04/06/11 1 of 9. Page ID #: 652
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF OHIO
WESTERN DIVISION
IN RE: DEPUY ORTHOPEDICS, INC.,
MDLDOCKETNO.1:10md 2197
AMENDED STIPULATED
ASR HIP IMPLANT PRODUCTS
EXPLANT PRESERVATION ORDER
LIABILITY LITIGATION
-This Document Relates To:
ALL CASES
EXPLANT PRESERVATION ORDER·
Upon the submissions of the parties and for good cause shown,
IT IS HEREBY ORDERED ADJUDGED AND DECREED that:
(1) Pursuant to the Court’s duty to supervise pretrial proceedings in this case, including
discovery, and pursuant to -the Court’s inherent power, the Court hereby orders, effective
immediately, that DePuy Orthopaedics, Inc. (“Defendant”) and Plaintiffs (collectively, ‘’the Parties”)
shall comply with the following directives relating to the preservation of explants in the abovecaptioned matter:
A.
Definitions
Device Subject to This Order
The provisions of this Order shall pertain to the following:
1.
DePuy ASR Device means the ASR Hip System Device and components marketed
and sold by Defendant in the United States.
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2.
Explanted DePuy ASR Device means the ASR Hip System Device and
components explanted from patients in the United States, and tissue samples if retrieved during
surgery. The provisions of this Order shall also pertain to any other DePuy ASR Devices that have
been explanted and returned to Defendant that, through reasonable efforts, can be identified
as having been implanted in any patients in the United States (hereinafter all referred to as
“Explanted DePuy ASR Devices”).
B.
Preservation Protocol
The Parties agree that the Preservation Protocol, appended hereto as Exhibit A, represents
a reasonable protocol designed for the preservation of Explanted DePuy ASR Devices and
surrounding tissues which may constitute evidence related to any design or manufacturing claim
which Plaintiffs may assert in this litigation: Defendant will not object to the request by or on
behalf of a Plaintiff that the explanting surgeon and/or hospital retain and preserve synovial fluid
and/or whole blood/serum pursuant to retention and preservation procedures to be established by
and for that individual Plaintiff.
Recognizing that each explant procedure is within the purview and control of non-party
medical practitioners and hospitals where surgeries occur, any departure from the attached
Preservation Protocol by non-party medical practitioners and hospitals shall not constitute the
spoliation of evidence by any of the Parties.
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C.
Physical Evidence
The Parties shall make good faith’ efforts with non-party medical practitioners and hospitals
to preserve any Explanted DePuy ASR Devices within their possession, custody or control that may
be relevant to the claims, defenses, or subject matter of this litigation. Defendant will not take
steps which inhibit requests by or on behalf of a Plaintiff to have their surgeon and/or hospital
retain and preserve any Explanted DePuy ASR, Device, synovial fluid; and/or whole blood/serum
or any other physical evidence.
1.
Non-Destructive Inspection and Analysis.
Non-destructive inspection and analysis by, the Parties or their designated contract
laboratory(s) of Explanted DePuy ASR Devices, are allowed. The Parties agree that the “Procedure
for Laboratory Inspection of ASR, ASR-XL and Related ,Components” (“Inspection Protocol’’), one
of the Preservation Protocols appended hereto as Exhibit A, represents a reasonable non-destructive
protocol designed for the inspection of Explanted DePuy ASR Devices which may constitute evidence
related to any design or manufacturing claim which Plaintiffs may assert in this litigation. The Parties
will not object to any inspection of Explanted DePuy ASR Devices which is reasonably consistent
with the Inspection Protocol, and this Order, and any inspection of Explanted DePuy ASR Devices
which is reasonably consistent with the Inspection Protocol, and this Order, shall not constitute the
spoliation of evidence by any of the Parties. If counsel of record for a Plaintiff so chooses, a Plaintiff’s
Explanted DePuy ASR Device may be obtained from the Plaintiff’s surgeon or the hospital where the
surgery occurred and sent to a contract laboratory(s) of Plaintiff’s choice, or a designated storage
facility, subject to the requirement that the explant shall be preserved in accordance with the attached
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Preservation Protocol and inspection and analysis shall be non-destructive, and reasonably
consistent with the attached Inspection Protocol, and this Order Absent that choice by counsel
of record for a Plaintiff, DePuy will make arrangements for Explanted DePuy ASR Devices to be
sent to Orthopaedic Hospital, Los Angeles, California, with the requirement that the explant shall
be preserved in accordance with the attached Preservation Protocol and inspection and analysis
shall be non-destructive, and reasonably consistent with the attached Inspection Protocol, and
this Order. Except as pennitted’in the attached Preservation Protocol and Inspection ProtOCOl, the
parties will take reasonable measures with their, respective contract laboratories and/or designated
storage facilities to maintain the Explanted DePuy ASR Devices, including all component parts, in
the same condition as they were in when received, including refraining from altering the structure,
,existence, integrity and nature of the device surfaces as explanted. Except as otherwise permitted
by this Order, all Explanted DePuy ASR Devices obtained by the Parties from surgeons or from the
hospital where a Plaintiffs surgery occurred shall be retained by the receiving party, its designated
contract laboratory(s) or designated storage facility unless otherwise agreed by the Parties.
2.
Surgically Removed DePuv ASR Device in Plaintiffs’ or Defendant’s
Possession
In the event that prior to the entry date of this Order, an Explanted DePuy ASR Device has
been obtained by either Plaintiffs or Defendant, the Parties agree as follows:
(i)
For each Plaintiff who has obtained an Explanted DePuy ASR Device, notice of that
fact will be provided to Defendant, along with information as to the date of the explantation,
the location of the explant, whether synovial fluid and/or whole blood/serum were retained, and
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an acknowledgement that the explant will be preserved, and that any further inspection and
testing shall be in accoroance with the provisions of .this Order and the attached Preservation
Protocol
(ii)
For each Plaintiff for whom DePuy may have obtained an Explanted DePuy ASR
Device, notice of that fact will be provided to Plaintiff’s Counsel of record, along with· information
as to the date of the explantation, the location of the explant, and an acknowledgement that
the explant will be preserved, and that any further inspection and testing shall be in accordance
with the provisions of this Order and the attached Preservation Protocol. Upon request, DePuy will
return the explant to Plaintiff’s counsel of record upon receipt of an acknowledgement that the
explant will be preserved, inspected and tested in accordance with the provisions of this Order
and the attached protocols. If the request for forwarding arrives prior to the completion of the
testing and inspection, then (a) the inspection shall stop immediately and (b) the DePuy laboratory
shall seek approval to either complete the inspection or will forward the device as requested. If a
Plaintiff’s Explanted DePuy ASR Device was obtained prior to the entry of this Order, and has been
inspected or tested, the results of such inspection and testing shall be made available to counsel
of record for the opposing party. The Parties agree that the mere failure to follow the Preservation
Protocol attached to this Order for such Explanted DePuy ASR Devices received prior to the entry
of this Order shall not constitute the spoliation of evidence.
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D.
Inspection Results-
The Parties agree to exchange the results of-all inspection-and testing done by their
respective contract laboratory(s) on all Explanted DePuy ASR Devices, including the exchange of
all data generated as a result of the inspection and testing, photographs, and other information
generated as a result of the inspection and testing Preservation Protocol attached to this Order.
1.
For Defendant Obtained Explanted DePuy ASR Devices
For Explanted DePuy ASR Devices obtained from surgeons or hospitals by Defendant, upon
request and after the completion of the inspection and testing by Defendant’s contract laboratory,
Plaintiff has the right, at their expense, to request that their Explanted DePuy ASR Device be sent
to it contract laboratory of Plaintiffs choice for further inspection and testing. Plaintiff is entitled
to receive the results of the inspection and testing performed by or at the request of Defendant,
including the exchange of all data generated as a result of the inspection and testing, photographs,
and other information genereted as a result of the inspection. Defendant is entitled to receive the
results of the inspection and testing performed at the request of Plaintiff, including the exchange
of all data generated as a result of the inspection and testing, photographs, and other information
generated as a result of the inspection.
2.
For Plaintiff Obtained Explanted DePuy ASR Devices
For Explanted DePuy ASR Devices obtained from surgeons or hospitals by Plaintiff,
upon request and after the completion of the inspection and testing by Plaintiff’s contract
laboratory. Defendant has the right, at their expense, to request that the Explanted DePuy
ASR Device and synovial fluid and/or whole blood/serum, if retained, and if any remains after
Plaintiff’s testing, be sent to a contract laboratory of Defendant’s choice for further inspection
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and testing. Defendant is entitled to receive the results of the inspection and testing performed at
the request of Plaintiff, including the exchange of all data generated as a result of the inspection
and testing, photographs, and other information generated as a result of the inspection, including
any information or data from the testing of synovial fluid and/or whole blood/serum. Plaintiff
is entitled to receive the results of the inspection and testing performed by or at the request of
Defendant, including the exchange of all data generated as a result of the inspection and testing,
photographs, and other infoIination generated as a result of tbe inspection.
(i)
If Plaintiff has taken possession of an Explanted DePuy ASR Device and has chosen
not to conduct an inspection or testing, Defendant shall have the right to request that the
Explanted DePuy ASR Device be sent to a contract laboratory of Defendant’s choice for inspection
and testing. Plaintiff is entitled to receive the results of the inspection and testing, including the
exchange of all data generated as a result of the inspection and testing, photographs, and other
information generated as a result of the inspection. Upon completion of Defendant’s inspection
and testing, Plaintiff shall be entitled to have the Explanted DePuy ASR Device sent to a contract
laboratory of Plaintiff’s choice for further inspection and testing, with Defendant entitled to receive
the results of the inspection and testing, including the exchange of all data generated as a result
of the inspection and testing, photographs, and other information generated as a result of the
inspection.
E.
Dissemination of this Order
Defendant shall disseminate this Order to surgeons and hospital representatives who
were recipients of its letter dated September 30, 2010, regarding “Retention of Explanted
Components,” and in addition to distributors of Defendant’s ASR Device with a request that the
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distributors disseminate to its representatives, and by doing so, shall be deemed to have satisfied
the Court’s expectation that this Order be communicated to non-party medical practitioners and
hospitals. The Parties agree that neither will promote or encourage third parties, including but not
limited to physicians and hospital personnel, to act in a way that is inconsistent with this Order or
the Preservation Protocols.
F.
Court Oversight of the Process
The process of obtaining from surgeons and hospitals Explanted DePuy ASR Devices, and
then sending for inspection, and testing hundreds if not thousands of Explanted DePuy ASR Devices
at contract laboratories, is likely to encounter complications which the Parties and this Court
cannot anticipate at this time. The Court shall retain an active involvement in this process and
the Parties shall keep the Court advised of complications encountered. In the event that a dispute
arises between a hospital and a Patient or Patient’s counsel regarding the retrieved components,
the Patient or Patient’s counsel has a right to seek relief in this Court and this Court will intervene
to resolve this dispute. To facilitate the Court’s involvement in resolving any complications arising
from this Order, the Court designates Plaintiff’s Executive Committee member Eric Kennedy
(216.781.111, [email protected]) and Defense Counsel Bob Tucker (216.696.4093,
[email protected]) as the contact persons who will field any questions and who will
bririg to the Court those issues requiring Court involvement.
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Case: 1:10-md-02197-DAK Doc #: 127-1 Filed:04/06/11 1 of 28. Page ID #: 661
EXHIBIT A
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Procedure for the Decontamination and Preservation of Retrieved DePuy
ASR or ASR-XL Components and Preservation of Tissue Samples by the
Hospital or Healthcare Center and Prior to the Shipment to the Storage
Facility or Contract Laboratory Retained by Either DePuy or the Patient
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Decontamination/Preservation Procedure
Procedure for the Decontamination and Preservation of Retrieved DePuy ASR or ASR-XL Components and
Preservation of Tissue Samples by the Hospital or Healthcare Center and Prior to. the Shipment to the
Storage facility or Contract -Laboratory Retained by Either DePuy or the Patient.
1.
PURPOSE:
The following is an agreed upon protocol for giving instruction to outside parties for the
decontamination of retrieved DePuy ASR or ASR-XL components and the preservation of possible
tissue sample(s).
2.
3.
4.
SCOPE:
2.1
THIS PROCEDURE ONLY APPLIES TO ALL DEVICES AND POSSIBLE TISSUE SAMPLE(S) THAT ARE
RetRIEVED DURING AND LEADING UP TO THE REVISION SURGERY FOR DEPUY ASR OR ASR·XL
COMPONENTS.
2.2
While not being requested by DePuy, DePuy does not object to a patient or the patients
counsel of record making other arrangements for the retention, preservation and shipping by it
surgeon and/of the hospital of synovial fluid and whole blood serum for an individual patient.
2.3
Decontamination, preservation and shipment of DePuy devices that do not involve the revision
of DePuy ASR or ASR-XL components are to be handled in ·the customary manner.
PRECAUTIONS:
3.1
Only personnel trained in handling and shipping infectious substances shall perform this
procedure.
3.2
Standard precautions for biOlogical materials ml:lst be used when handling the retrieved
components and possible tissue samples.
DECONTAMINATION OF EXPLANTS AND PRESERVATION OF TISSUE SAMPLES:
4.1
Retrieved components ·shall be decontaminated in accordance with hospital procedures unless
a Patient-or Patient’s counsel of record requests that it be done in a different fashion. DePuy
does not object to a patient or a patient’s counsel of record making other arrangements with
the patient’s surgeon and/or the hospital for the fixation or decontamination of retrieved
components in a manner other than in accordance with hospital procedures so long as the
retrieved components are appropriately decontaminated and preserved.
4.1:1. In the event that a dispute arises between a hospital and Patient or Patient’s counsel
regarding the manner in which the retrieved components should be decontaminated,
preserved and/or·shipped, until resolved, the retrieved components shall remain
completely immersed in 10% Neutral Buffered Formalin without any alteration or
decontamination. If the Patient or Patient’s counsel objects to autoclaving, autoclaving
should not take place without an order from the Court permitting same.
DPYUS 109
Page 1 of 2
Rev. C; Mar 23, 2011
57
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Decontamination/Preservation Procedure
4.2. Tissue samples are to be fixed according to hospital pathology procedures, remain soaked in
the fixative and retained in a leak proof container marked as “biohazard” and “hazardous” in
accordance with hospital procedures for the fixative unless a patient or a patient’s counsel of
record requests that it be done in a different fashion. DePuy does not object to a patient or a
patient’s counsel of record making other arrangements with the patient’s surgeon andlor the
hospital for the fixation. of tfssue samples in a manner other than in accordance with hospital
procedures so long as the tissue samples are appropriateiy preserved.
5.
4.3
The total sample volume should not be larger than a golf ball in size and should only be taken
from tissue removed from areas adjacent to the revised implant that may contain debris from
the subject device.
4.4
DePuy does not object to a patient or a patient’s counsel of record requesting the retention
and preservation of synovial fluid and/or whole blood to be packaged, preserved, and shipped
in accordance with procedures to be agreed upon by the patient, her counsel of record, and
the surgeon and/or hospital.
PACKAGING AND TRACKING
5.1
6.
DPYUS 109
5.1.1
DePuy’s procedure for shipment of retrieved DePuy ASR or ASR XL components from
the hospital or Healthcare center to the DePuy contract laboratory OR : .
5.1.2
Per the patient or patient’s counsel seeking transfer of these materials pursuant to a
duly executed authorization.
STORAGE:
6.1
7.
After the decontamination and preservation of retrieved components and after the
preservation of tissue, hospitals and health care centers are, to the extent possible, to follow
the packaging, tracking and shipment instructions provided by either:
The retrieved components and possible tissue samples should be stored in a secured location
until a shipping kit and instructions arrive from DePuy, the patient or a representative of the
patient.
REFERENCES:
7.1
Title 21 CFA, Part.803., Medical Device Reporting
7.2
Title 29 CFR, Part 1910, Occupational Safety and Health Standards
7.3
ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health
care facilities
Page 2 of 2
Rev. C; Mar 23, 2011
58
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VI.Reimbursement
for Physician
Administrative
Time
59
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Reimbursement for Administrative Time Associated with Identifying
and Notifying Patients about the Voluntary ASR™ Recall
For information regarding reimbursement for administrative time associated with the ASR recall, please
contact the DePuy ASR Support Line at 1-866-230-9597.
Document ID: DPYUS 66 (version 1)
Last updated August 8, 2012
60
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VII. Reimbursement
for Patients
61
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Healthcare Professionals Treating
ASR™ Hip System Patients:
DePuy would like to share important claims
and reimbursement information with you.
In August 2010, DePuy voluntarily recalled the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System.
DePuy is committed to working with patients and their health insurers to address medical costs directly associated with the
recall. DePuy will also address recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages
and travel costs.
Because you are the orthopaedic provider for ASR patients, you and your office will play a critical role in
the reimbursement process. In the following diagrams, we provide more detailed information about your role in the
claims and reimbursement process for patients with and without insurance.
• Diagram #1 (Healthcare Professional Patient Claim/Reference Number Initiation): Your patients may initiate
a claim with our third party claims processor, Broadspire, on their own. Alternatively, you may initiate a claim
for your patients, as explained in Diagram #1. In order to complete this process, you will be asked to fill out and
submit the DePuy Orthopaedics ASR Product Recall Reporting Form (DPYUS 42).
• Diagram #2 (ASR Hip System Treatment Reimbursement Process for Insured Patients): If a patient is
insured, please follow the claim and expense submittal process explained in Diagram #2. DePuy is committed
to working with patients and their health insurers to address medical costs directly associated with the recall.
DePuy will also address recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost
wages and travel costs. ASR patients with recall-related out-of-pocket expenses should contact the ASR Help Line,
1-888-627-2677, for assistance and evaluation of these claims.
• Diagram #3 (ASR Hip System Treatment Reimbursement Process for Uninsured Patients): If a patient is
uninsured, please submit claims for medical services directly to Broadspire, as explained in Diagram #3. Patients
should submit out-of-pocket expenses directly to Broadspire.
We recognize that your office will need to follow some new processes to receive reimbursement for the care
and treatment of ASR patients, and we thank you for your patience, flexibility and understanding. While we
realize that this recall may be concerning for you and your patients, we are working to make the reimbursement process
as efficient as possible.
Please do not hesitate to contact DePuy if we can help you. If you have any questions, please call DePuy’s toll free
number at 866-230-9597. Additional information and forms are available at ASRrecall.DePuy.com.
Please submit all completed forms by mail, fax, or email to:
Broadspire P.O.
Box 608 | Berkeley Heights, NJ 07922-0608
Fax: (866) 350-0843
E-mail: [email protected]
Page 1 of 3
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Diagram #1: Healthcare Professional Patients Claim/Reference Number Initiation
To initiate Patient
Claim/Reference
Number Process
with Broadspire
HCP submits intake
documents to
Broadspire*
HCP
Broadspire assigns
Patient Claim/
Reference Number
*Intake Documents:
• ASR Product Recall Reporting
Form (DPYUS 42)
Patient
Broadspire issues
Claim/Reference
Number and request
for ASR implant
verification (if not
provided) sent to HCP
Broadspire Claims
Adjustor sends Claim/
Reference Number
and Letter of Payment
authorization
to patient
HCP sends ASR
implant verification
records to Broadspire
Broadspire verifies
ASR records
Verification
Complete
• Medical Authorization form
(DPYUS 11 Version 3)
• Verification of ASR (if available)
Diagram #2: ASR™ Hip System Treatment Reimbursement Process for Insured Patients
HCP submits claims
for medical services to
primary insurer
HCP submits patient
expenses (co-pay, deductible,
etc.) to Broadspire
Patient submits out-of-
pocket expenses (travel,
meals, etc.) to Broadspire
Primary insurer reviews
claim submission under
standard contracts and
claim filing requirements
Broadspire reviews submission,
verifies ASR and
eligible expenses
verifies ASR and
eligible expenses
Broadspire provides
reimbursement for eligible
patient expenses (co-pay,
deductible, etc.) to HCP
Broadspire provides
reimbursement for eligible
out-of-pocket expenses
to patient
Primary insurer provides
reimbursement using standard
process to HCP*
Broadspire addresses claims
for reimbursement with
primary insurer
*If an office receives notification of a denial of a claim for reimbursement
by the payor, notify Broadspire and provide a copy of the denial notice.
Page 2 of 3
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Diagram #3: ASR™ Hip System Treatment Reimbursement Process for Uninsured Patients
HCP submits claims for reimbursement for
Patient submits out-of-pocket expenses
medical services to Broadspire
(travel, meals, etc.) to Broadspire
Broadspire reviews claim submission according
to established usual and customary rates
verifies ASR and eligible expenses
Broadspire provides reimbursement
Broadspire provides reimbursement
for eligible claims to HCP
for eligible out-of-pocket expenses to patient
Page 3 of 3
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DePuy Orthopaedics ASR™ Hip System Recall
Reporting Form Instructions
The following information provides instructions for assisting patients with a DePuy ASR™ Hip System with the claims
initiation and reimbursement process. DePuy is committed to working with patients and their health insurers to address
medical costs directly associated with the recall. DePuy will also address recall-related patient out-of-pocket expenses,
such as co-pays, deductible expenses, lost wages and travel costs.
You can assist a patient in initiating the ASR claims process by completing the following steps:
1. Complete the DePuy Orthopaedics ASR Product Recall Reporting Form: Submit ASR-related patient
information using the DePuy Orthopaedics ASR Product Recall Reporting Form (DPYUS 42). Enter the requested
information electronically or print the form and fill it out for mailing to the address below.
2. Complete the Authorization Form and have the patient review and sign the second page: U.S. privacy
laws do not permit disclosure of personally identifiable patient information to DePuy, or to DePuy’s third party
claims processor, Broadspire, without written patient authorization. A signed Authorization Form (identified in the
lower lefthand corner as DPYUS 11, version 3) must be provided with the completed recall reporting form. Please
note that signing this form does not waive the patients’ rights to pursue legal action.
3. Complete and submit the form by mail, fax, or e-mail to:
Broadspire
P.O. Box 608
Berkeley Heights, NJ 07922-0608
Phone: (866) 874-2865
Fax: (866) 350-0843
E-mail:[email protected]
Once this information is received by Broadspire, the following steps will take place:
1. A record (claim) is started.
2. A claims representative will contact the patient.
3. The claims representative will send the patient a Letter of Payment Authorization and an ASR claim number. The
patient should provide the Letter of Payment Authorization to cover eligible costs each time the patient sees a
medical professional for evaluation/treatment associated with the ASR recall. The claims representative will explain
how these costs should be documented and submitted.
4. The patient should submit any expenses and documentation to Broadspire at the address listed above for review
for eligibility.
If you have any questions or would like to initiate a claim, please call the ASR Help Line at 888-627-2677. Additional
information is available on www.depuy.com, including the process for submitting information in an easy-to-read chart.
65
DEPUY ORTHOPAEDICS ASR PRODUCT RECALL REPORTING FORM
Fax to (866) 350-0843 OR
E-mail to [email protected] OR
Mail to Broadspire, PO Box 608, Berkeley Heights, NJ 07922
A. INFORMATION ON THE INDIVIDUAL COMPLETING THIS FORM
*YOUR CONTACT PHONE:
*YOUR NAME:
YOUR RELATIONSHIP TO THE PATIENT:
RELATIVE OR FRIEND
SELF
OTHER
MEDICAL PROFESSIONAL
________________
B. PATIENT INFORMATION
*PATIENT NAME (FIRST, MI, LAST):
*PATIENT ADDRESS, CITY, STATE, ZIP:
*PATIENT PHONE NUMBER:
* AGE:
* GENDER:
C. GENERAL CLAIM INFORMATION
TYPE OF DEPUY ASR HIP (IF KNOWN):
DePuy ASR Resurfacing Replacement
PRODUCT CODE (XXXX-XX-XXX)
* DATE OF SURGERY TO
IMPLANT ASR:
DePuy ASR XL Acetabular System
LOT CODE:
RIGHT
WHICH HIP WAS REPLACED WITH AN ASR?
LEFT
BOTH
* NAME OF SURGEON WHO PERFORMED SURGERY TO IMPLANT ASR HIP
(FIRST, MI, LAST):
* HOSPITAL NAME WHERE ASR HIP IMPLANT SURGERY OCCURRED:
* HOSPITAL ADDRESS:
*HOSPITAL CITY, STATE, ZIP:
* DESC OF SYMPTOMS/PROBLEM PATIENT IS EXPERIENCING:
*HAS PATIENT VISITED A PHYSICIAN/SURGEON RELATED TO THE RECALL?
*HAS THE ASR HIP IMPLANT BEEN REMOVED?
YES
NO
YES
PENDING
NO
UNKNOWN
IF YES OR PENDING, WHAT IS THE REMOVAL SURGERY DATE?
D. MEDICAL FACILITY SUMMARY - WHERE PATIENT VISITED DUE TO RECALL OR FOR REVISION SURGERY TO REMOVE THE ASR HIP IMPLANT
NAME OF THE PHYSICIAN/SURGEON VISITED DUE TO RECALL (FIRST, MI, LAST):
PHYSICIAN ADDRESS:
PHYSICIAN CITY, STATE, ZIP:
BUSINESS PHONE:
HOSPITAL NAME WHERE REVISION SURGERY WAS COMPLETED:
*HOSPITAL ADDRESS:
*HOSPITAL CITY, STATE, ZIP:
NAME OF SURGEON WHO PERFORMED SURGERY TO REMOVE ASR HIP, IF
DIFFERENT FROM ABOVE (FIRST, MI, LAST):
SURGEON ADDRESS:
SURGEON CITY, STATE, ZIP:
E. ADDITIONAL INFORMATION
COMMENTS:
PLEASE NOTE: The report MUST be accompanied by an Authorization Form (also known as Medical Release Form, DPYUS 11, version 3) signed by
the patient.
I HAVE INCLUDED THE SIGNED PATIENT AUTHORIZATION FORM
Attention surgeons: Please be sure to include your patient’s record labels and/or operative notes to Broadspire indicating whether your patient’s hip
replacement is a DePuy implant, and specifically, the DePuy ASR™ Hip System.
This form should only be used for patients who have the ASR Hip System.
DPYUS 42
DPYUS 42
*Indicates a mandatory field
Last updated November 3, 2010
(*) Indicates a Mandatory Field.
11/3/2010
contact
VIII. ASR Codes
67
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ASR Hip System Recall Part Code Listing
US codes
510(k) Cleared
Part Number US 510k
510k ASR Acetabular Cups 9998‐00‐744
9998‐00‐746
9998‐00‐748
9998‐00‐750
9998‐00‐752
9998‐00‐754
9998‐00‐756
9998‐00‐758
9998‐00‐760
9998‐00‐762
999805764
999805966
999806168
999806370
510k ASR femoral primary heads (aka hemis) 9998‐90‐039
9998‐90‐041
9998‐90‐043
9998‐90‐045
9998‐90‐046
9998‐90‐047
9998‐90‐049
9998‐90‐051
9998‐90‐053
9998‐90‐055
9998‐90‐057
9998‐90‐059
9998‐90‐061
9998‐90‐063
510k ASR fem XL modular heads 9998‐90‐239
9998‐90‐241
9998‐90‐243
9998‐90‐245
9998‐90‐246
9998‐90‐247
9998‐90‐249
9998‐90‐251
9998‐90‐253
9998‐90‐255
999890157
999890159
999890161
999890163
DPYUS 20
Description
ASR ACETABULAR IMPLANT 44
TOTAL ASR ACET IMP SIZE 64
ASR FEMORAL IMPLANT SIZE 39
ASR UNI FEMORAL IMPL SIZE 39
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US codes
510(k) Cleared
Part Number US 510k
Description
Adapter Sleeves
9998‐90‐340
9998‐90‐343
9998‐90‐346
9998‐90‐349
9998‐00‐312
9998‐00‐315
9998‐90‐333
9998‐90‐353
9998‐00‐318
ASR TAP SLV ADAP 11/13 +0 ASR TAP SLV ADAP 11/13 +3 ASR TAP SLV ADAP 11/13 +6 ASR TAP SLV ADAP 11/13 +9 ASR TAP SLV ADAP 12/14 +2 ASR TAP SLV ADAP 12/14 +5 ASR TAP SLV ADAP 11/13 ‐3
ASR TAP SLV ADAP 12/14 ‐1
ASR TAP SLV ADAP 12/14 +8 510k ASR fem XL Anatomic modular heads and tapers (same Int) 999899025
ASR XLA SML Sleeve 11/13 ‐3
999899035
ASR XLA SML Sleeve 11/13 +0
999899045
999899055
999899019
999899029
ASR XLA STD Sleeve 11/13 ‐3
999899039
ASR XLA STD Sleeve 11/13 +0
999899049
999899059
999899069
510k ASR 300 Cups (same as Int)
999830744
999830746
999830748
999830750
999830752
999830754
999830756
999830758
999830760
999830762
999830764
999830766
999830768
999830770
ASR 300 Size 44
ASR 300 Size 46
ASR 300 Size 48
ASR 300 Size 50
ASR 300 Size 52
ASR 300 Size 54
ASR 300 Size 56
ASR 300 Size 58
ASR 300 Size 60
ASR 300 Size 62
ASR 300 Size 64
ASR 300 Size 66
ASR 300 Size 68
ASR 300 Size 70
Additional Codes
999800764
999800766
DPYUS 20
ASR ACETABULAR CUPS 64
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US codes
DPYUS 20
510(k) Cleared
Part Number US 510k
Description
999800768
999800770
999890257
999890259
999890261
999890263
999800139
999800141
999800143
999800145
999800146
999800147
999800149
999800151
999800153
999800155
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US codes
IDE Study (In progress)
Part Number US IDE
IDE/PMA ASR Acetabular Cups 9998‐00‐044
9998‐00‐046
9998‐00‐048
9998‐00‐050
9998‐00‐052
9998‐00‐054
9998‐00‐056
9998‐00‐058
9998‐00‐060
9998‐00‐062
9998‐00‐064
9998‐00‐066
9998‐00‐068
9998‐00‐070
IDE ASR femoral heads ‐ obsolete
9998‐01‐532
9998‐01‐534
9998‐01‐536
9998‐01‐538
9998‐01‐539
9998‐01‐540
9998‐01‐542
9998‐01‐544
9998‐01‐546
9998‐01‐548
9998‐01‐550
9998‐01‐552
9998‐01‐554
9998‐01‐556
PMA ASR femoral heads 9998‐03‐039
9998‐03‐041
9998‐03‐043
9998‐03‐045
9998‐03‐046
9998‐03‐047
9998‐03‐049
9998‐03‐051
9998‐03‐053
9998‐03‐055
9998‐03‐057
9998‐03‐059
9998‐03‐061
9998‐03‐063
DPYUS 20
Description
TOTAL ASR FEM IMP SIZE 39
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International Codes
International Part Number Commercial
International ASR Acetabular Cups 999803944
999804146
999804348
999804550
999804652
999804754
999804956
999805158
999805360
999805562
999805764
999805966
999806168
999806370
International ASR femoral primary heads
999803239
999803441
999803643
999803845
999803946
999804047
999804249
999804451
999804653
999804855
999805057
999805359
999805561
999805763
International ASR fem modular XL heads
999890139
999890141
999890143
999890145
999890146
999890147
999890149
999890151
999890153
999890155
999890157
999890159
999890161
999890163
DPYUS 20
Description
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International Codes
DPYUS 20
Description
999800200
999800203
999800206
999800209
999800102
999800105
999800300
999800303
999800313
999800201
999800207
999800108
ASR TAP SLV ADAP 11/13 +0 ASR TAP SLV ADAP 11/13 +3 ASR TAP SLV ADAP 11/13 +6 ASR TAP SLV ADAP 11/13 +9 ASR TAP SLV ADAP 12/14 +2 ASR TAP SLV ADAP 12/14 +5 ASR TAP SLV ADAP 9/10 0
ASR TAP SLV ADAP 9/10 +3
ASR TAP SLV ADAP 11/13‐3
ASR TAP SLV ADAP 12/14 +8 999899039
999899041
999899043
999899045
999899046
999899047
999899049
999899051
999899053
999899055
999899057
999899059
999899061
999899063
ASR XL Anatomic Head Size 39
999899018
999899028
999899038
999899048
999899058
999899014
999899024
999899034
999899044
999899054
ASR XLA +8 Sleeve 12/14 ‐3.5
ASR XLA +8 Sleeve 12/14 ‐1
ASR XLA +8 Sleeve 12/14 +2
ASR XLA +4 Sleeve 12/14 ‐3.5
ASR XLA +4 Sleeve 12/14 ‐1
510k ASR 300 cups (same as US) 999830744
999830746
999830748
ASR 300 Size 44
ASR 300 Size 46
ASR 300 Size 48
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International Codes
Description
999830750
999830752
999830754
999830756
999830758
999830760
999830762
999830764
999830766
999830768
999830770
ASR 300 Size 50
ASR 300 Size 52
ASR 300 Size 54
ASR 300 Size 56
ASR 300 Size 58
ASR 300 Size 60
ASR 300 Size 62
ASR 300 Size 64
ASR 300 Size 66
ASR 300 Size 68
ASR 300 Size 70
Additional International Codes
999800238
999800240
999800242
999800244
999800245
999800246
999800248
999800250
999800252
999800254
999800256
999800258
999800260
999800262
Modular Femoral Head 38
256688236
256688371
256688402
256688495
256688628
256688799
812899170
812899207
812899226
812899337
812899456
812899532
ASR Total Femoral Implant Size 55 RSA
ASR Total Acetabular Implant RSA Size 54
Additional codes
999800046
999800048
999800050
DPYUS 20
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International codes
DPYUS 20
International
Part Number Commercial
Description
999800052
999800054
999800056
999800058
999800060
999800062
999800064
999800066
999800068
999801534
999801536
999801538
999801540
999801542
999801544
999801546
999801548
999801550
999801552
999801554
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IX.Forms
76
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Forms Available in This Publication
DPYUS 11 (Version 4) Authorization to Use or Disclose Information
DPYUS 36 (Version 2) LabCorp Phlebotomist Instructions/Blood Test Order Form
DPYUS 67 (Version 1) Whole Blood Collection Recommendation Update
DPYUS 68
Quest Diagnostics Blood Test Order Form
DPYUS 41 (Version 1) ASR™ Hip System Recall Reporting Form: Instructions for Claims Initiation
DPYUS 42
Broadspire ASR Product Recall Reporting Form
77
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581-0988
USA
Tel: +1 (800) 366 8143
Fax: +1 (574) 267 7196
www.depuy.com
©DePuy Orthopaedics, Inc. 2013.
All rights reserved.
DPYUS 59 v4
0313

DePuy ASR™ Hip Recall Resource Packet

Transcription

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