GRIPTION® TF

Transcription

GRIPTION® TF

Design Rationale/Surgical Technique
GRIPTION TF
®
Table of
contents
Augment, Shim, and Buttress Portfolio..........................................4
GRIPTION® TF Augments System Overview....................................5
GRIPTION TF Buttress System Overview..........................................6
GRIPTION TF Shim System Overview..............................................7
Advanced Materials........................................................................8
Advanced Fixation........................................................................10
Advanced Instrumentation...........................................................12
Advanced Modularity...................................................................14
Key Bone Stock and Landmark Considerations............................15
Treatment by Defect Algorithm....................................................16
Pre-operative Planning and Templating........................................17
GRIPTION TF Surgical Technique...................................................18
Acetabular Preparation.................................................................19
Implant Insertion..........................................................................22
Buttress Plate/Shim Surgical Technique.........................................27
Ordering Information...................................................................30
References....................................................................................36
2
GRIPTION TF
®
Filling
the gap in
acetabular
revision
surgery
Advanced
Materials
Advanced
Instrumentation
Advanced
Fixation
GRIPTION TF
®
Augment, Shim,
and Buttress Portfolio
DePuy’s GRIPTION TF Acetabular Revision
System is an innovative technology for
addressing bone defects in complex
acetabular revision surgery. It represents
the latest advances in materials, fixation
and instrumentation technologies. Combined
with other elements of the PINNACLE® Hip
Solutions portfolio – including the leading
acetabular cup system and advanced bearing
options – the result is a winning solution to
help restore motion for today’s revision patients.
GRIPTION TF Augments
System Overview
®
Advanced
geometry
provides
increased
surface area
for bone
contact.
The GRIPTION TF Augments are designed to
act as a defect filling implant in the case of
severe bone loss in the acetabulum.
Pin holes enhance
visualization &
assessment of
Augment fit and
suitability.
Directional
screw holes
engineered
to maximize
fixation
capability.
Proprietary
TRUEBOND™
locking slot to help
mechanically secure
Augment to
acetabular shell.
Tight radius inner
diameter on
Augment to achieve
precise fit with cup.
Screwhole cutaways
to optimize fit with
PINNACLE Cup
System.
5
GRIPTION TF Buttress
System Overview
®
The GRIPTION TF Buttress is designed to
support the shell in a similar manner as the
Augments, however the Buttress implant
spans the defect in the acetabulum and
is cemented to the shell.
Tapered curved surface for
ease of implantation
Screw holes for use with 5.5mm
locking/non-locking cortical screws
Screw holes for use with
6.5mm cancellous screws
Curved spherical radius to mate
with Acetabular Shell
6
Neutral, left and right configurations available for different implant positioning
GRIPTION TF Shim
System Overview
®
The GRIPTION TF Shim implants are designed
to mate with the Buttress to raise the end
of the Buttress when pelvic geometries
require support.
Available
in 5, 10 and
15-degree
configurations
Oversized
holes for
clearance
of locking/
non-locking
screws
Advanced
Materials
The GRIPTION TF material is a completely
porous structure made from commercially
pure titanium. It provides a modulus of
elasticity similar to bone, and a coefficient
of friction that allows for initial scratch fit.
Advanced
Materials
Advanced
Instrumentation
Advanced
Fixation
Coefficient of Friction
1.02
1.00
0.98
0.96
0.94
0.92
0.90
0.88
0.86
0.84
0.82
GRIPTION TF
Augments1
Zimmer™
Augments2
n
Bone-like Modulus of Elasticity
Bone-like Modulus of Elasticity
GPa
20
GPa
20
15
15
10
10
5
5
0
Zimmer™
2
Augments
Zimmer™
Augments2
0
GRIPTION TF1 Zimmer™ 4
GRIPTION TF
1
Zimmer
™4
Cortical
Bone
Cortical
Bone
Cancellous
Bone
Cancellous
Bone
Compressive Yield Strength
Compressive Yield Strength
MPa
250
MPa
250
200
200
150
150
100
100
50
50
0
0
GRIPTION TF
Augments1
GRIPTION TF
Augments1
Zimmer™
3
Augments
Zimmer™
Augments3
9
Advanced
Fixation
Locking
Screw Option
GRIPTION TF implants have the ability to use
locking screws to fixate the Augment or
Buttress to the cup and bone. Locking screws
Advanced
Materials
help prevent the screw from becoming loose
and backing out of the Augment and cup.
This helps eliminate the risk of compromising
the fixation as a result of screw migration.
In addition, GRIPTION TF allows surgeons to
Advanced
Instrumentation
10
Advanced
Fixation
implant diverging locking screws for even
stronger fixation to the host bone.
Cement,
Cementless or
Hybrid Fixation
Options
Prior to the availability of the GRIPTION TF Augments, the only
method of fixating the Augment to the cup was with bone
cement. The introduction of the GRIPTION TF Augments allow
surgeons to select between cementless, cemented and hybrid
options of Augment to cup fixation.
TRUEBOND™ Cementless Technology
Hybrid Fixation
Cemented
Advanced
Instrumentation
The DePuy GRIPTION TF Revision
System is the only Augment and
Buttress system that provides
specialized instruments to
prepare a customized bone
envelope for the GRIPTION TF
Advanced
Materials
implants. The GRIPTION TF
Revision System allows surgeons
to select two methods of
preparing the acetabular bone
with their choice of modular
or finishing rasps. Featuring
Advanced
Instrumentation
Advanced
Fixation
easy connect technology, the
GRIPTION TF system-specific
instruments are user-friendly
and innovative, making them
a valuable complement to
your technique.
Finishing rasp
Modular rasp
13
Advanced
Modularity
The DePuy GRIPTION TF Augments and Buttresses
are compatible with the PINNACLE Hip Solutions
Acetabular system. The PINNACLE Hip Solutions
provide the largest selection of advanced bearing
technologies, biological and mechanical
fixation alternatives. With more implant designs
Bantam 38-46mm
and choices than any competitive system, you’ll
never have to compromise when meeting the
individual needs of patients.
100 series 44-66mm
Fix
Duo
tion*
t
Po
ro
c
Ultamet
oa
AltrX
c
ro
oa
t
Po
BIOLOX delta
AltrX
Standard Metal
M-Spec
Ultamet
AltrX
Grip
Grip
aSphere M-Spec
Po
ro
co
a
AltrX
t
oa
c
ro
Po
Marathon
t
Marathon
Deep Profile 54-72mm
Grip
tion
14
Fix*
Fix
Duo
Revision
54-80mm
Ultamet
Duo
Multi-Hole
48-72mm
Marathon
tion
Marathon
tion
Sector 48-66mm
Grip
Fix
Duo
*Gription and DuoFix are currently not indicated for use
with the CoMplete™ Acetabular Hip System.
Key Bone Stock
and Landmark
Considerations
Radiographic landmarks can be helpful in
assessing the acetabular bone stock. It can
also be useful to order a CT scan of the
area with a metal suppression technique.
A CT scan will often indicate significantly
more lysis than what is apparent on plain
radiographs, and can also aid in determining
pelvic discontinuities or loss of structural bone.
Bone Stock
Considerations
Completely supportive acetabulum –
PINNACLE Hip Solutions Shell
Partially supportive acetabulum –
PINNACLE Hip Solutions Shell with
Non-supportive –
PINNACLE Hip Solutions Shell with possible
need for Augment, Buttress or cage
Anatomic landmarks
1. Acetabular teardrop – integrity of medial wall and inferior portion
of anterior and posterior column
2. Kohler’s line – integrity of medial wall and superior anterior column
3. Ischial lysis – integrity of posterior wall and posterior column
Possible Surgical Solutions
by Defect Classification
The Paprosky Classification is the most
widely used defect classification.5
Type 1
• Anterior/posterior columns are intact
and supportive
• Greater than 70 percent of host bone
to hemispherical shell contact
Type 2A
• Anterior/posterior columns are intact
and supportive
• Superior migration less than 2cm
• Up to 30 percent of the cup may be uncovered superiorly
Type 2B
• Superior migration less than 2cm
• Anterior/posterior columns are supportive
• Greater than 50 percent of host bone to
hemispherical shell contact
Type 2C
• Rim is intact but distorted
• Medial wall defect and superior head center
migration (<2cm)
• Teardrop is obliterated
Type 3A
• 30-60 percent of rim unsupportive
• Greater than 2cm superior migration
• Less than 50 percent of host bone to
hemispherical shell contact
Type 3B
• Greater than 60 percent of rim unsupportive
• Significant lysis and loss of posterior column
bone stock
• Risk of pelvic discontinuity
Surgical
Technique
Pre-operative Planning
and Templating
Using the standard DePuy PINNACLE acetabular shell
templates, the surgeon can determine the approximate
size of the revision shell that may be required, including
the possibility of jumbo cups (>66mm diameter), deep
profile cups, or acetabular Augments. Assessing the
acetabular bone stock is of great importance in helping
the surgeon to anticipate the possible structural defects
that may be encountered during the surgery.
17
GRIPTION TF
Surgical
Technique
®
Once the acetabulum has been exposed and evaluated
preparation for the acetabular construct can begin.
Start by reaming the acetabulum with an undersized
reamer at a level that will restore the appropriate center
of rotation. Ream concentrically with progressively larger
reamers – maintaining appropriate opening abduction
and anteversion. Reaming should stop when adequate rim
contact has been obtained excluding the defect region.
At this point, the surgeon has 3 options for preparing the
acetabular defect to accept the GRIPTION TF Augment:
• Finishing Rasp
• Modular Rasp
• Free hand Technique
18
Acetabular
Preparation
Finishing Rasp
Technique
Once the acetabular cavity has been prepared, place the
hemispherical acetabular trial into the prepared bed at
the correct center of rotation.
Choose the appropriately sized finishing rasp and start
preparing the acetabular defect by keeping the inside
diameter of the finishing rasp against the outer surface
of the acetabular trial.
Advance the rasp slowly until the desired seating level
is obtained. If it appears that there is not intimate bone
contact with the rasp, increasing to the next size of rasp
may be necessary, repeating the steps above until
adequate bone contact has been obtained. Once the
defect has been prepared satisfactorily, tap the
appropriate GRIPTION TF Augment trial into place.
If the trial is stable, then the defect is appropriately
prepared. If adequate bone contact is not obtained,
or the trial is not stable, further preparation with larger
rasps may be needed. If the defect is such that adequate
bone contact and stability cannot be obtained, then
consideration should be given to utilizing a GRIPTION
TF Buttress to span the defect or possibly inverting the
acetabular Augment and using it as a Buttress.
Acetabular
Preparation
Continued
Modular Rasp
Technique
Once the acetabular cavity has been prepared, utilize the
half shell trial that is undersized by 1mm from the last
reamer or acetabular trial that was used. Place the trial
in the prepared acetabular cavity at the correct center of
rotation. Attach the modular rasp to the dovetail of the
trial and rotate the construct so that the rasp will prepare
the defect appropriately. Starting with the smallest size
rasp, prepare the defect utilizing progressively larger
rasps until the defect has been satisfactorily prepared to
accept the appropriate size Augment. Remove the half
shell trial and insert the appropriate full hemispherical
acetabular trial. The GRIPTION TF Augment trial can now
be placed into the defect and can be tapped into place.
If the trial is stable, the defect is appropriately prepared.
If adequate bone contact is not appreciated or the trial
is not stable, then further preparation with larger rasps
may be needed. If the defect is such that adequate bone
contact and stability cannot be obtained, then
consideration should be given to utilizing a
GRIPTION TF Buttress to span the defect.
Once appropriate stability has been obtained for the
Augment trial, the real Augment is ready to be placed.
Free Hand
Technique
Once the acetabular cavity has been prepared,
a hand held burr can be utilized to prepare and
shape the remaining acetabular defect in order
to accommodate the GRIPTION TF Augment trial.
Care should be taken to remove only the minimum
amount of bone necessary to accommodate the
trial Augment. Frequently test the defect to avoid
unnecessary bone removal using the trial.
21
Implant
Insertion
Once the acetabulum and the acetabular defect
have been prepared to accept the acetabular shell
and Augment, the surgeon can decide to place
either the shell first and then the Augment, or
the Augment can be placed initially and the shell
placed secondarily. In addition, at the time of
insertion of the shell and Augment, the surgeon
should decide whether cement fixation or
mechanical fixation will be utilized to join the
Augment to the acetabular shell. It is important
at the time of shell insertion to orient the shell
appropriately so that a screw can be placed
through one of the screw holes in the shell and
also through the fixation slot in the Augment if
mechanically mating.
Acetabular
Shell-First Technique
After preparation of the acetabulum and
Note:
Acetabular shells should be
placed at 45 degrees of abduction
and 15 degrees of anteversion.
22
accompanying defect has been completed,
insert the acetabular shell in accordance with
the PINNACLE Acetabular Cup system technique.
Acetabular Shell-First
Technique, Continued
Tip:
Use the 3.8 drill bit for the
6.5mm cancellous screws.
Use the 3.8 drill bit for the
5.5mm locking screw.
If using 5.0 screw, use the 3.2
drill bit which is utilized
with the PINNACLE
Revision System.
Screws for supplemental fixation may be placed at this
point if necessary. The surgeon should pay close attention
to any shift in position of the shell that may occur
secondary to placing and tightening down the screws.
If the shell requires placement of the Augment to provide
stability of the construct, tightening the screws before
placing the Augment may shift the shell slightly. This may
cause difficulty in placing the Augment if the acetabular
defect has been prepared in a precise manner. If a shift
in position of the acetabular shell is noted, the screws
should be backed out slightly to allow the appropriate
placement of the Augment and then re-tighten. If the
shell is stable without initial screw fixation the screws
can be placed after the Augment has been inserted.
Once the acetabular shell is in place, if cement mating
of the two components is desired, a bead of doughy
cement should be placed on the outer surface of the
shell prior to placing the Augment.
The Augment inserter tip should be placed on the
flat surface of the Augment in the two center holes.
The Augment can then be tapped into place behind
the acetabular shell and into the prepared defect.
Implant
Insertion
Acetabular Shell-First
Continued
be performed. The knurled, threaded pins can be
Additional screw fixation of the Augment can then
used to help stabilize the Augment during screw
insertion if necessary.
Alternatively, the surgical assistant can stabilize the
Augment with the inserter tip until provisional screw
fixation is obtained. Tapered head, 5.5mm locking
or 5.0mm non-locking screws should then be placed
utilizing the standard technique.
If mechanical mating of the shell and Augment is
desired, then once the shell and Augment are in
place, a standard PINNACLE 6.5mm screw can be
placed through the shell and the fixation slot of the
Augment. Special care should be taken to ensure
that the head of the screw is fully seated within
the acetabular shell.
Tip:
Use the 3.8 drill bit for the 6.5mm cancellous screws.
Use the 3.8 drill bit for the 5.5mm locking screw.
If using 5.0 screw, use the 3.2 drill bit which is utilized
with the PINNACLE Revision System.
Augment-First
Technique
After the preparation of the acetabulum and
accompanying defect has been completed, the
acetabular Augment can now be placed. Using
the Augment 90-degree inserter tip, place the
inserter into the holes on the inside diameter
of the Augment.
The Augment can now be impacted into the defect
or held in place with the inserter. Insert the knurled,
threaded pins through the holes in the flat face of
the Augment to provide provisional fixation.
Screw fixation utilizing either 5.5mm locking or
5.0 mm non-locking screws can now be performed.
If desired, supplemental fixation utilizing the inside
diameter holes of the Augment can now be
performed as well. Special care should be taken to
ensure that the screw heads are fully seated and
flush or countersunk slightly when utilizing the
inner diameter fixation holes.
Tip:
For pre-drilling the inner diameter screw,
the angled 45-degree drill bit may be easier
to use than a straight drill bit.
25
Implant
Insertion
Augment-First
Continued
desired, a bead of doughy cement can now be
If cement mating of the shell and Augment is
placed on the inner diameter of the Augment and
the acetabular shell can be impacted in the standard
fashion. Supplemental screw fixation of the shell can
now be undertaken in the standard fashion.
If hybrid mating of the shell and Augment is also
desired, the shell should be carefully positioned
during impaction so that the fixation slot of the
Augment lines up with an appropriate dome hole in
the acetabular shell. The shell should be impacted
utilizing the standard PINNACLE acetabular cup
surgical technique. Once the shell is in position,
supplemental screw fixation of the shell can be carried out in the standard fashion. Additional 6.5mm
screws may be placed through the appropriate dome
hole in the shell and through the fixation slot in the
Augment. Special care should be taken to ensure
that this screw head is fully seated within the inside
diameter of the shell.
Tip:
26
Bone wax on the tip of the inserter may assist holding
the Augment on the inserter device.
Buttress/
Shim
Surgical
Technique
In some cases, the acetabular defect will require a
Buttress rather than a simple acetabular Augment in
order to provide appropriate stabilization of the acetabular
construct. Once this has been determined, exposure of
the iliac wing is required. In most cases a large elevator
can be used to subperiosteally elevate the abductor
musculature from the ilium to adequately allow placement
of the Buttress in the correct position. In cases where
exposure is difficult it may be necessary to perform some
type of trochanteric osteotomy or trochanteric slide or a
variant thereof to aid in exposure of the iliac wing in the
supra-acetabular area.
The initial preparation of the acetabulum should be carried
out as noted above in the technique for the standard
Augment. A hemishpherical trial should then be inserted.
Different Buttress trials should then be evaluated to see
which configuration – straight, anterior column or posterior
column best addresses the defect. Since pelvic geometries
differ significantly, shims can be trialed as well to help
position, raise and angulate the Buttress so that it
accommodates both the defect and its apposition to the
acetabular shell optimally. The shim trials snap onto the
Buttress trials to aid in the ease of trialing, especially in
the face of a difficult exposure. The shims can be oriented
Tip:
Select screws that are longer than the
combined thickness of the Buttress and Shim.
in 90 degree increments since the screw holes in the shims
match up with those in the Buttress.
Buttress/
Shim
Surgical
Technique
Continued
It should be noted that, since the Buttress does not
have to be in intimate contact with the acetabular
shell being used, a Buttress which is smaller or larger
than the acetabular shell can be utilized if they
appear to provide a more appropriate fit.
Buttress Insertion
Once the appropriate position of the Buttress has
been determined, the surgeon has the choice of
which to implant first: the acetabular shell or the
Buttress. If the acetabular shell is placed first, it is
impacted in the standard fashion and supplemental
screw fixation is utilized if necessary. If a shim is to be
utilized on the Buttress, the two components must
be cemented together utilizing bone cement in a
doughy phase with the shim in the same position in
which it was trialed. Care should be taken to remove
any excess cement from the fixation holes in the
shim and Buttress. Once the cement has hardened,
a bead of cement should be placed on the surface
of the acetabular shell which will abut the contact
area of the Buttress. Again, the Buttress does not
have to make intimate contact with the shell if
leaving a small gap results in a better fit.
Buttress Insertion,
Continued
The Buttress construct can then be placed and held in
position with the knurled, threaded guide pins while
screw fixation is being performed or alternatively it can be
held manually. 6.5mm screws are then utilized in the two
holes closest to the acetabular shell and either 5.5mm
locking or 5.0mm non-locking screws can be utilized in
the 4 holes that are more proximal. The distal holes of the
Buttress allow for divergent placement of the screws to
aid in obtaining the best bony fixation possible.
Alternatively, if the Buttress is to be placed first, the
above technique can be utilized as well. Once the
Buttress has been anchored, a bead of cement is placed
on the contact area of the Buttress and the acetabular
shell is then inserted utilizing the standard technique.
Care should be taken when inserting screws into the
Buttress plate to avoid potential neurovascular injury.
29
®
Catalog Code
1217-10-150
1217-10-154
1217-10-158
1217-10-162
1217-10-166
1217-10-170
1217-15-250
1217-15-254
1217-15-258
1217-15-262
1217-15-266
1217-15-270
1217-20-350
1217-20-354
1217-20-358
1217-20-362
1217-20-366
1217-20-370
1217-30-450
1217-30-454
1217-30-458
1217-30-462
1217-30-466
1217-30-470
Description
GRIPTION TF Augment size 50/52 x 10
GRIPTION TF Buttress
®
30
Catalog Code
1217-00-156
1217-00-256
1217-00-356
1217-00-162
1217-00-262
1217-00-362
1217-00-168
1217-00-268
1217-00-368
Description
GRIPTION TF Buttress 56 Neutral
GRIPTION TF Buttress 56 Left
GRIPTION TF Buttress 56 Right
GRIPTION TF Shims
®
Catalog Code
1217-00-105
1217-00-110
1217-00-115
Description
GRIPTION TF Shim 5 Degrees
GRIPTION TF Instruments
®
Case One: Trial Case
Catalog Code
8299-13-505
Description
5.5mm LOCKING SCREW CADDY
Catalog Code
2217-10-150
2217-10-154
2217-10-158
2217-10-162
2217-10-166
2217-10-170
2217-15-250
2217-15-254
2217-15-258
2217-15-262
2217-15-266
2217-15-270
2217-20-350
2217-20-354
2217-20-358
2217-20-362
2217-20-366
2217-20-370
2217-30-450
2217-30-454
2217-30-458
2217-30-462
2217-30-466
2217-30-470
Description
GRIPTION TF Augment size 50/52 x 10 Trial
®
Case One: Trial Case
Catalog Code
2217-00-156
2217-00-256
2217-00-356
2217-00-162
2217-00-262
2217-00-362
2217-00-168
2217-00-268
2217-00-368
2217-00-105
2217-00-110
2217-00-115
2366-83-000
2274-36-000
2274-09-000
2366-84-000
2274-12-000
2366-85-000
2217-01-518
2217-01-519
2217-01-505
2217-01-506
2217-01-507
2217-01-508
2217-01-509
9505-02-071
2217-01-501
2217-01-502
2217-01-517
2217-01-516
2217-01-503
2217-01-500 Description
GRIPTION TF Buttress 56 Neutral Trial
GRIPTION TF Buttress 56 Left Trial
GRIPTION TF Buttress 56 Right Trial
GRIPTION TF Shim Trial 5 Degrees
45-Degree Angle Drill
Duraloc Depth Gauge
Duraloc Drill Bit 3.8 Dia 10mm
3.8mm Drill Bit 25mm
Duraloc Drill Bit 3.8 Dia 40mm
3.8mm Drill Bit 50mm
Headed Drill PINNACLE 15mm
HP Power PINNACLE Driver
Augment Insert Tip Top
Augment Insert Tip 90 Degree
Rasping Power Adaptor
Rasping Strike Plate
Augment Rasping Handle
Augment Adjustable Handles
®
Case Two: Finishing Rasp Case
Catalog Code
2217-10-550
2217-10-554
2217-10-558
2217-10-562
2217-10-566
2217-10-570
2217-15-550
2217-15-554
2217-15-558
2217-15-562
2217-15-566
2217-15-570
2217-20-550
2217-20-554
2217-20-558
2217-20-562
2217-20-566
2217-20-570
2217-30-550
2217-30-554
2217-30-558
2217-30-562
2217-30-566
2217-30-570
Description
PINN AUGMENT FIN RASP 50X10
PINN AGUMENT FIN RASP 50X30
Case Three: Modular Rasp Case
Catalog Code
2217-01-550
2217-01-554
2217-01-558
2217-01-562
2217-01-566
2217-01-570
Description
PINN AUGMENT MOD RASP 50/52
33
®
Case Three: Modular Rasp Case
Catalog Code
Description
2217-01-649
HALF SHELL TRIAL 49mm
2217-01-653
2217-01-657
2217-01-661
2217-01-665
2217-01-669
2217-01-580
PINN AUGMENT RASP +5mm OFFSET
2217-01-582
2217-01-584
Buttress Screw Options: 6.5mm Cancellous Screws
Catalog Code
Description
121715500
PINN CAN BONE SCREW 6.5mmX15mm
121720500
121725500
121730500
121735500
121740500
121745500
121750500
121755500
121760500
121765500
121770500
34
Buttress Screw Options: 5.5mm PolyAxial Locking Screws
Catalog Code
Description
815355014
5.5mm POLYAXIAL SCREW FT 14mm
815355016
815355018
815355020
815355022
815355024
815355025
815355030
®
Augment Screw Options: 5.5mm PolyAxial Locking Screws
Catalog Code
Description
815355025
815355030
815355035
815355040
815355045
815355050
815355055
815355060
815355065
815355070
Augment Screw Options: 5.5mm PolyAxial Non-Locking Screws
Catalog Code
Description
815455040
5.5mm NONLOCK SCREW PT 40mm
815455045
815455050
815455055
815455060
815455065
815455070
Augment Screw Options: 5.0mm Cancellous Screws
Catalog Code
Description
125725000
5.0mm DIA TPRD HD PER SCRW 25
125730000
125735000
125740000
125745000
125750000
125755000
125760000
125765000
125770000
DePuy GRIPTION TF Acetabular Augment System
®
Important
This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary
information.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
INDICATIONS
The DePuy GRIPTION TF Acetabular Augments, Buttresses and Shims are indicated for use with the PINNACLE Acetabular Cup System, the PINNACLE Bantam
Acetabular Cup System and the PINNACLE Revision Acetabular Cup System for total hip replacement in the following conditions:
severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia; avascular necrosis of the femoral head;
acute traumatic fracture of the femoral head or neck; failed previous hip surgery; and certain cases of ankylosis.
INTENDED USE
The porous GRIPTION TF titanium acetabular Augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled
Augment/acetabular cup construct is intended for cemented or cementless use.
The porous GRIPTION TF titanium shim is affixed to the mating Buttress using bone cement. This porous GRIPTION TF titanium Buttress is affixed to the mating
acetabular cup using bone cement. The assembled Buttress/acetabular cup construct is intended for cemented or cementless use.
CONTRAINDICATIONS
Absolute contraindications include: infection, sepsis, and osteomyelitis.
Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who is incapable of following directions, 2) osteoporosis, 3) metabolic
disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone
loss or bone resorption apparent on roentgenogram, and/or 7) vascular insufficiency, muscular atrophy, or neuromuscular disease.
WARNINGS AND PRECAUTIONS
Ceramic-coated femoral stem prostheses are indicated for uncemented press fit fixation.
CAUTION: DO NOT USE BONE CEMENT FOR FIXATION OF A CERAMIC COATED PROSTHESIS.
Components labeled for “Cemented Use Only” are to be implanted only with bone cement. The following conditions tend to adversely affect hip replacement
implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, history of infections, severe deformities leading
to impaired fixation or improper positioning, tumors of the supporting bone structures, allergic reactions to materials, tissue reactions, and disabilities of other joints.
ADVERSE EVENTS
The following are the most frequent adverse events after hip arthroplasty, change in position of the components, loosening of components, wear or fracture of
components, dislocation, infection, peripheral neuropathies, tissue reaction.
REFERENCES
1. DePuy Orthopaedics, Inc. Data on file.
2. Zhang Y, Ahn PB, Fitzpatrick DC, Heiner AD, Poggie RA, Brown TD. “Interfacial frictional behavior: cancellous bone, cortical bone, and a novel porous tantalum
biomaterial.” J Musculoskel Res. 1999;3(4):245-251.
3. Krygier JJ, Bobyn JD, Poggie RA, et al. “Mechanical characterization of a new porous tantalum biomaterial for orthopaedic
reconstruction.” Proc SIROT (International Research Society of Orthopaedic Surgery and Traumatology). Sydney Australia, 1999.
4. http://www.zimmer.com/z/ctl/op/global/action/1/id/9193/template/MP/prcat/M6/prod/y
5. Paprosky, W.G., P.G. Perona and M.J. Lawrence. “Acetabular Defect Classification and Surgical Reconstruction in Revision Arthroplasty: A 6-Year Follow-Up
Evaluation.” The Journal of Arthroplasty 9(1),1994:33-44.
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. 2011.
All rights reserved.
0612-04-511
36

GRIPTION® TF

Transcription

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