Original ME Müller® Low Profile Cup

Original
M.E. Müller®
Low Profile Cup
Surgical Technique
Evolution of a Proven Concept
2
Original M.E. Müller® Low Profile Cup
Disclaimer
This document is intended exclusively for physicians and is not intended for laypersons.
Information on the products and procedures contained in this document is of a general nature and does not represent and does not
constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic
statement with regard to any individual medical case, each patient must be examined and advised individually, and this document
does not replace the need for such examination and/or advice in whole or in part.
Information contained in this document was gathered and compiled by medical experts and qualified Zimmer personnel. The information
contained herein is accurate to the best knowledge of Zimmer and of those experts and personnel involved in its compilation. However,
Zimmer does not assume any liability for the accuracy, completeness or quality of the information in this document, and Zimmer is not
liable for any losses, tangible or intangible, that may be caused by the use of this information.
3
Original M.E. Müller® Low Profile Cup
Surgical Technique
Original M.E. Müller
Low Profile Cup
Table of Content
Original M.E. Müller Low Profile Cup
4
Indications
5
Contraindications
5
Preoperative Planning
6
Surgical Technique 7
Surgical Approach 7
Exposure of the Acetabulum 7
Reaming the Acetabulum 7
Drilling Holes into the Acetabulum
8
Cleaning the Acetabulum
8
Insertion of the Bone Cement
8
Precompression of the Cement
9
Insertion and Orientation of the Cup
9
Implants 10
Combination with Rings and Cages 12
Instruments 14
Hi-Fatigue™ Bone Cement 15
4
Original M.E. Müller® Low Profile Cup
Original M.E. Müller Low Profile Cup
With more than 875,000 implantations
worldwide, and over 25 years of clinical
use, the Original M. E. Müller® (M.E.M.)
Low Profile Cup is a widely applied und
trusted solution for replacement of the
ace­tabu­lum. The cup is designed with
a macrostructured surface to ensure
optimal fixation in the cement mantle.
The Original M.E. Müller Low Profile Cup
shows excellent clinical results* and
convinces surgeons by its ease of use.
* List of publications is shown in the Original M.E. Müller
Low Profile Cup brochure Lit. No. 06.01601.012.
5
Original M.E. Müller® Low Profile Cup
Indications
Contraindications
The Original M.E. Müller Low Profile
Cup is applicable for various indications, ranging from simple primary
cases to complex cases in revision. For
best clinical results, the implant must
be embedded in a stable acetabular
structure. In cases of poor bone quality
or deficient bone stock, the Original
M.E. Müller Low Profile Cup can be
combined with cages or rings to ensure
optimal fixation. The system offers a
cost-effective and simple solution for:
The use of the Original M.E. Müller Low
Profile Cup alone should not be
considered in presence of poor bone
quality where the use of a ring or cage
is indicated.*
• Primary hip replacement if the bone
quality is adequate and there is
sufficient bone coverage
• Primary hip replacement when combined with an ARR-Ring (Aceta­bular
Roof Reinforcement Ring), e.g. for
DDH cases (Developmental Dysplasia
of the Hip)
• For revision cases with the use of
a ring or a cage
* For correct use of rings and cages, please refer to the respective surgical technique brochure.
6
Original M.E. Müller® Low Profile Cup
Preoperative Planning
Preoperative planning is key to a good
surgical outcome. Planning allows to
anticipate potential surgical compli­
cations while determining size and
position of the implant intended to be
used. In cases of acetabular dysplasia,
planning is essential in deciding
whether to consider the aid of grafts,
rings, or cages.*
The basis for the preoperative planning
is provided by X-ray images and
product-specific templates. To find the
correct center of rotation, and thus to
ensure correct leg length, the anatomy
of the healthy pelvis is first mirrored to
the affected side. The template is then
placed onto the patient’s radiograph to
determine the correct size and position
of the acetabular component. The cup
should be placed at an inclination of
approximately 35°–40° with reference
to the pelvic line, and at approximately
15° ± 5° of anteversion. It should be
noted that correct placement of the cup
may also depend on positioning of the
femoral component. The antetorsion of
the femoral component should be in
the range of 10°–15°.
Size 36
REF-Number of the Product:
63.22.36
∅ 22 Sulene-PE
20 cm
Size 38
REF-Number of the Product:
63.22.38
∅ 22 Sulene-PE
15 cm
Size 40
REF-Number of the Product:
63.22.40
∅ 22 Sulene-PE
10 cm
Size 42
5 cm
REF-Number of the Product:
63.22.42
∅ 22 Sulene-PE
63.28.42
∅ 28 Sulene-PE
01.00284.042 ∅ 28 Durasul
Magnification
1.15:1
10 cm
5 cm
15 cm
Original M.E. Müller™ Low Profile Cup, Cemented
Lit. No. 06.00807.000x – Ed. 9/2007 WL
+H8440600807000X1/$070901I07Z
This reference number must correspond to that
of the prosthesis to be implanted. © All rights reserved,
Zimmer GmbH, CH-8404 Winterthur, Switzerland
* For correct use of rings and cages, please refer to the respective surgical technique brochure.
7
Original M.E. Müller® Low Profile Cup
Surgical Technique
Surgical Approach
The Original M.E. Müller Low Profile
Cup can be implanted using a variety of
surgical approaches. The specific approach depends on the surgeon’s preference and therefore may differ from
the procedure shown below.
Exposure of the Acetabulum
A clean exposure of the acetabulum is
necessary to successfully implant the
cup. Fibrous, cartilaginous bone
structures and osteophytes must be
removed from the area, as they prevent
the preparation of the acetabulum.
Reaming the Acetabulum
A hemispherical acetabular cavity is
prepared using hemispherical reamers.
Bear in mind that the sizes of reamers
don’t include the cement mantle thickness, i.e. for the use of a 52 mm cup, a
reamer with size 54 mm is required.
Fig. 1
Starting with the smallest reamer the
acetabulum is reamed in medial direction until the preplanned center of
rotation is achieved (Fig. 1).
Warning: Depending on the type of
reamer used, the design of cutting
holes and thus the cutting behaviour
can differ.
Surgeons must then adapt the orien­
teation of the reamer. Then, the reamer
with the size of the preselected cup is
chosen to attain the zone of vascular
bleeding and to form the cavity (Fig. 2).
Fig. 2
8
Original M.E. Müller® Low Profile Cup
Drilling Holes into the
Acetabulum
Depending on the size of the acetabulum, a number of anchorage holes are
drilled along the rim of the acetabulum
(Fig. 3). These holes should be around
5 mm in diameter and have a depth of
around 0,5–1 cm.
Cleaning the Acetabulum
Bone debris from reaming and drilling
is washed out. Gauze is pressed firmly
into the acetabular cavity to minimize
bleeding.
Fig. 3
Insertion of the Bone Cement
The gauze is removed from the ace­
tabulum and the required amount of
cement is packed into the area. With
the use of injection or the finger-packing method, cement is first placed into
the anchorage holes, followed by the
acetabular area (Fig. 4).
Please refer to the product usage brochures of the specific bone cement
for more details on their usage
(Lit. No. 97-1120-001-00).
Fig. 4
9
Original M.E. Müller® Low Profile Cup
Precompression of the Cement
Surgical techniques for use of cement
can vary by product; please refer to
the respective cement for more details.
Insertion and Orientation
Of the Cup
The predetermined cup is positioned
by hand on the semiviscous cement
bed. It has to be pushed in first horizontally and then as far in a medial
direction as possible (Fig. 5).
Fig. 5
Excess cement is removed with the
narrow curette (Fig. 6). With the help
of a cup-positioning instrument with
ring, the cup is then aligned at an angle
of 35°–40° and with an anteversion
of 10°–15° (Fig. 7). Continuous pressure is used to move the cup until it
is seated evenly into the reamed ace­
tabulum. The positioning top is then
removed to avoid further changes of
cup positioning.
The top for the impactor without rim is
then used to apply pressure to the
area, and excess cement is trimmed
from the acetabulum (Fig. 6). Continuous pressure should be applied to the
cup until cement polymerization is
complete. A trial reduction is then
performed with the implanted stem
and trial heads.
Fig. 6
Fig. 7
10
Original M.E. Müller® Low Profile Cup
Implants
M.E. Müller®
Low Profile Cup, cemented
Details
Details
UHMW Polyethylene
(Sulene® PE)
Radiological mark
CP Titanium
(Protasul® Ti)
UHMW Polyethylene
(Sulene® PE)
Radiological mark
CP Titanium
(Protasul® Ti)
22 mm
Details
28 mm
UHMW Polyethylene
(Sulene® PE)
Radiological mark
CP Titanium
(Protasul® Ti)
32 mm
Size [mm]
REF
Size [mm]
REF
Size [mm]
REF
361
381
401
42
44 46 48 50 52 54 56 58 –
–
–
63.22.36
63.22.38
63.22.40
63.22.42
63.22.44
63.22.46
63.22.48
63.22.50
63.22.52
63.22.54
63.22.56
63.22.58
–
–
–
–
–
–
421
44
46
48
50
52
54
56
58
60
62
64
–
–
–
63.28.42
63.28.44
63.28.46
63.28.48
63.28.50
63.28.52
63.28.54
63.28.56
63.28.58
63.28.60
63.28.62
63.28.64
–
–
–
–
441
461
48
50
52
54
56
58
60
62
64
–
–
–
–
63.32.44
63.32.46
63.32.48
63.32.50
63.32.52
63.32.54
63.32.56
63.32.58
63.32.60
63.32.62
63.32.64
1
Must be used in combination with cages and rings.
11
Original M.E. Müller® Low Profile Cup
M.E.Müller®
Low Profile Cup, cemented
Details
Details
Durasul®
Radiological mark
CP Titanium
(Protasul® Ti)
Durasul®
Radiological mark
CP Titanium
(Protasul® Ti)
28 mm
EO
Details
32 mm
Durasul®
Radiological mark
CP Titanium
(Protasul® Ti)
EO
36 mm
EO
Size [mm]
REF
Size [mm]
REF
Size [mm]
REF
42
44
46
48
50
52
54
56
58
60
62
64
01.00284.042
01.00284.044
01.00284.046
01.00284.048
01.00284.050
01.00284.052
01.00284.054
01.00284.056
01.00284.058
01.00284.060
01.00284.062
01.00284.064
–
44
46
48
50
52
54
56
58
60
62
64
–
01.00324.044
01.00324.046
01.00324.048
01.00324.050
01.00324.052
01.00324.054
01.00324.056
01.00324.058
01.00324.060
01.00324.062
01.00324.064
–
–
–
48
50
52
54
56
58
60
62
64
–
–
–
05.95001.050
05.95001.051
05.95001.052
05.95001.053
05.95001.054
05.95001.055
05.95001.056
05.95001.057
05.95001.058
12
Original M.E. Müller® Low Profile Cup
Combination with Rings and Cages
Principle
Choice of Original M.E. Müller Low
Profile Cup size
• Biggest size applicable must corres­
pond to the nominal number of the
respective ring or cage (i.e. cup dia­
meter of maximum 50 mm is
allowed to use with a cage or ring
size 50)
• Otherwise use 1–2 sizes smaller
than the nominal number indicated
on the ring or cage
Choice of reamer
• Always use final reamer size of
+4 mm with respect to the final cup
diameter
• This will result in a true diameter of
+6 mm to consider the application
of a 2 mm cement mantle
Original M. E. Müller Ring
1
Original M.E. Müller Low Profile Cups
Ref.Number
Ring Outer
Diameter
(mm)
PE Cup
Diameter
(mm)
Sulene PE
22 mm
Sulene PE
28 mm
Sulene PE
32 mm
36
97.36.49
42
362
63.22.36
–
–
–
–
–
38
97.38.49
44
361
382
63.22.36
63.22.38
–
–
–
–
–
–
–
–
–
–
40
97.40.49
46
381
402
63.22.38
63.22.40
–
–
–
–
–
–
–
–
–
–
42
97.42.49
48
401
422
63.22.40
63.22.42
–
63.28.42
–
–
–
01.00284.042
–
–
–
–
44
97.44.49
50
421
442
63.22.42
63.22.44
63.28.42
63.28.44
–
63.32.44
01.00284.042
01.00284.044
–
01.00324.044
–
–
46
97.46.49
52
441
462
63.22.44
63.22.46
63.28.44
63.28.46
63.32.44
63.32.46
01.00284.044
01.00284.046
01.00324.044
01.00324.046
–
–
48
97.48.49
54
461
482
63.22.46
63.22.48
63.28.46
63.28.48
63.32.46
63.32.48
01.00284.046
01.00284.048
01.00324.046
01.00324.048
–
05.95001.050
50
97.50.49
56
481
502
63.22.48
63.22.50
63.28.48
63.28.50
63.32.48
63.32.50
01.00284.048
01.00284.050
01.00324.048
01.00324.050
05.95001.050
05.95001.051
52
97.52.49
58
501
522
63.22.50
63.22.52
63.28.50
63.28.52
63.32.50
63.32.52
01.00284.050
01.00284.052
01.00324.050
01.00324.052
05.95001.051
05.95001.052
54
97.54.49
60
521
542
63.22.52
63.22.54
63.28.52
63.28.54
63.32.52
63.32.54
01.00284.052
01.00284.054
01.00324.052
01.00324.054
05.95001.052
05.95001.053
56
97.56.49
62
541
562
63.22.54
63.22.56
63.28.54
63.28.56
63.32.54
63.32.56
01.00284.054
01.00284.056
01.00324.054
01.00324.056
05.95001.053
05.95001.054
58
97.58.49
64
561
582
63.22.56
63.22.58
63.28.56
63.28.58
63.32.56
63.32.58
01.00284.056
01.00284.058
01.00324.056
01.00324.058
05.95001.054
05.95001.055
With a 2 mm cement layer
a 1 mm cement layer
2 With
Durasul
28 mm
Durasul
32 mm
Durasul
36 mm
13
Original M.E. Müller® Low Profile Cup
Burch-Schneider™ Reinforcement Cage
Original M.E. Müller Low Profile Cups
Ref. Number
Cage Outer
Diameter
(mm)
Cage Inner
Diameter
(mm)
PE Cup
Diameter
(mm)
Sulene
22 mm
Sulene
28 mm
Sulene
32 mm
Durasul
28 mm
Durasul
32 mm
Durasul
36 mm
40
01.00191.1401
01.00191.2402
46
42
383
404
63.22.38
63.22.40
–
–
–
–
–
–
–
–
–
–
44
01.00191.1441
01.00191.2442
50
46
423
444
63.22.42
63.22.44
63.28.42
63.28.44
–
63.32.44
01.00284.042
01.00284.044
–
01.00324.044
–
–
50
01.00191.1501
01.00191.2502
56
52
483
504
63.22.48
63.22.50
63.28.48
63.28.50
63.32.48
63.32.50
01.00284.048
01.00284.050
01.00324.048
01.00324.050
05.95001.050
05.95001.051
56
01.00191.1561
01.00191.2562
62
58
543
564
63.22.54
63.22.56
63.28.54
63.28.56
63.32.54
63.32.56
01.00284.054
01.00284.056
01.00324.054
01.00324.056
05.95001.053
05.95001.054
62
01.00191.1621
01.00191.2622
68
64
603
624
–
–
63.28.60
63.28.62
63.32.60
63.32.62
01.00284.060
01.00284.062
01.00324.060
01.00324.062
05.95001.056
05.95001.057
1
Left cage
2
Right cage
The size of the inlay should be chosen to be either the same size as the shell or smaller.
The thickness of the cement mantle varies accordingly.
3
With a 2 mm cement mantle
4
With a 1 mm cement mantle
Reinforcement Ring with Hook
Original M.E. Müller Low Profile Cups
Ref. Number
Ring Outer
Diameter
(mm)
PE Cup
Diameter
(mm)
Sulene PE
22 mm
Sulene PE
28 mm
Sulene PE
32 mm
Durasul
28 mm
Durasul
32 mm
Durasul
36 mm
36
94.16.23-36
42
362
63.22.36
–
–
–
–
–
38
94.16.23-38
44
361
382
63.22.36
63.22.38
–
–
–
–
–
–
–
–
–
–
40
94.16.23-40
46
381
402
63.22.38
63.22.40
–
–
–
–
–
–
–
–
–
–
42
94.16.23-42
48
401
422
63.22.40
63.22.42
–
63.28.42
–
–
–
01.00284.042
–
–
–
–
 44
94.16.23-44
50
421
442
63.22.42
63.22.44
63.28.42
63.28.44 
–
 63.32.44
 01.00284.042
01.00284.044
–
01.00324.044
–
–
46
94.16.23-46
52
441
462
63.22.44
63.22.46
63.28.44
63.28.46
63.32.44
63.32.46
01.00284.044
01.00284.046
01.00324.044
01.00324.046
–
–
48 
94.16.23-48
54
461
482
63.22.46
63.22.48
63.28.46
63.28.48
63.32.46
63.32.48
01.00284.046
01.00284.048
01.00324.046
01.00324.048
–
05.95001.050
50
94.16.23-50
56
481
502
63.22.48
63.22.50
63.28.48
63.28.50
63.32.48
63.32.50
01.00284.048
01.00284.050
01.00324.048
01.00324.050
05.95001.050
05.95001.051
52
94.16.23-52
58
501
522
63.22.50
63.22.52
63.28.50
63.28.52
63.32.50
63.32.52
01.00284.050
01.00284.052
01.00324.050
01.00324.052
05.95001.051
05.95001.052
54
94.16.23-54
60
521
542
63.22.52
63.22.54
63.28.52
63.28.54
63.32.52
63.32.54
01.00284.052
01.00284.054
01.00324.052
01.00324.054
05.95001.052
05.95001.053
56
94.16.23-56
62
541
562
63.22.54
63.22.56
63.28.54
63.28.56
63.32.54
63.32.56
01.00284.054
01.00284.056
01.00324.054
01.00324.056
05.95001.053
05.95001.054
58
94.16.23-58
64
561
582
63.22.56
63.22.58
63.28.56
63.28.58
63.32.56
63.32.58
01.00284.056
01.00284.058
01.00324.056
01.00324.058
05.95001.054
05.95001.055
60
94.16.23-60
66
581
602
63.22.58
–
63.28.58
63.28.60
63.32.58
63.32.60
01.00284.058
01.00284.060
01.00324.058
01.00324.060
05.95001.055
05.95001.056
62
94.16.23-62
68
601
622
–
–
63.28.60
63.28.62
63.32.60
63.32.62
01.00284.060
01.00284.062
01.00324.060
01.00324.062
05.95001.056
05.95001.057
64
94.16.23-64
70
621
642
–
–
63.28.62
63.28.64
63.32.62
63.32.64
01.00284.062
01.00284.064
01.00324.062
01.00324.064
05.95001.057
05.95001.058
1
With a 2 mm cement layer
2
With a 1 mm cement layer
14
Original M.E. Müller® Low Profile Cup
Instruments
for Original M.E. Müller Low Profile Cups
Tray instruments for low profile cup (complete)
ZS01.00245.626
Tray instruments for low profile cup (empty)
01.00245.627
Insert for tray instruments for
low profile cup (empty)
01.00245.628
Standard tray cover
01.00029.031
Cup impactor, curved
75.00.39
Positioning bar
75.85.00
Cup inserting device for cemented cups
(inner diameter)
∅ 22 mm
75.00.33
Top for impactor
black
∅ 22 mm
78.22.51*
blue
∅ 28 mm
78.28.51
green
∅ 32 mm
∅ 36 mm
78.32.51
05.95001.060*
Cup impactor, straight
75.00.49
Positioning guide 40°
75.85.19
Positioning top for low profile cups, black
∅ 22 mm
75.22.94
Test cup, low profile
∅ 36 mm
54.36.08
∅ 38 mm
54.38.08
∅ 40 mm
54.40.08
∅ 42 mm
54.42.08
∅ 44 mm
54.44.08
∅ 46 mm
54.46.08
∅ 48 mm
54.48.08
∅ 50 mm
54.50.08
∅ 52 mm
54.52.08
∅ 54 mm
54.54.08
∅ 56 mm
54.56.08
∅ 58 mm
54.58.08
∅ 60 mm
54.60.08
∅ 62 mm
54.62.08
∅ 64 mm
54.64.08
Positioning top for low profile cups
blue
∅ 28 mm
75.28.94
green
∅ 32 mm
75.32.94*
black
∅ 36 mm
05.95001.059*
*
On special request
15
Original M.E. Müller® Low Profile Cup
Hi-Fatigue™* Bone Cement
Function and Sense of Hi-Fatigue Bone Cement
Bone cement, in general, is a
synthetic plastic material which is
based on resin and related to acrylic
glass. It is used:
• For fixation of artificial joints1
• For the transfer load from the
implant to bone
• As a shock absorber
Fatigue Testing
Due to its unique formulation,
Hi-Fatigue Bone Cement exhibits
outstanding improvement in dynamic
mechanical properties. This optimal
characteristic results in greater
reliability under long-term cyclical
loading.
Apart from anchoring the prosthesis,
bone cement fulfils the function of
transmitting the operating forces
onto a bigger surface. Furthermore
it acts as drug carrier (Hi-Fatigue G
Bone Cement) and helps keeping
the bone in a vital condition. The
handling of bone cement is described
mainly in four phases: mixing phase,
waiting phase, application phase
and setting phase. Zimmer brings in
an additional, very important phase:
the transport and storage phase.
All of these phases are influenced
by temperature and humidity.
Viscosity
The special viscosity properties of
Hi-Fatigue Bone Cement provide
optimal handling without pre-chilling.
The comfortable mixing phase of the
cement with low-viscosity properties
is followed by a short waiting time to
“dough up.” The effective handling
time results in an improved work­
ability of the Hi-Fatigue Bone Cement.
Broad Spectrum of Kill
Hi-Fatigue G Bone Cement contains
Gentamicin, which has a broad
spectrum of kill covering gram-positive and gram-negative bacteria.2 As
a premixed formulation, Hi-Fatigue G
provides a homogenous cement/
antibiotic mixture and saves valuable
OR time.
Hi-Fatigue Bone Cement –
Ideal Formula for Success
Hi-Fatigue Bone Cement can be
applied universally in the ortho­pedic
world and offers a multiplicity of
advantages:
• Improved dynamic mechanical
properties
• Optimal handling characteristics
• Short mixing and waiting phase
• Long working phase
• Processing without precooling
• Ideal for minimally invasive surgery
Ordering Information
Article
Quantity
REF
Hi-Fatigue Hi-Fatigue Hi-Fatigue G Hi-Fatigue G Hi-Fatigue G Hi-Fatigue G 1x 40 2 x 40 1x 20 2 x 20 1x 40 2 x 40 00-1120-140-01
00-1120-240-01
00-1121-120-01
00-1121-220-01
00-1121-140-01
00-1121-240-01
Outstanding Release Characteristics
Hi-Fatigue G Bone Cement provides
high local concentration of Gentamicin. With 0.55 grams of Gentamicin,
Hi-Fatigue G releases antibiotic
over several days to reduce the risk
of infection.3
* Hi-Fatigue™ is a trademark of aap Biomaterials
GmbH & Co. KG
1 Ascherl Rudolf. Science of Bone Cement, Ortho
Supersite
2 Foerster, G. v., Buchholz, H. W., Heinert, K.: Die
infizierte Hüftendoprothese-Spätinfektion nach
der 6. postoperativen Woche. In: Cotta, H.,
Braun, A. (Hrgs.), 124–135, 1988.
3 Data on file (aap Biomaterials GmbH & Co. KG)
Copyright 2009 by Zimmer GmbH Printed in Switzerland Subject to change without notice
Contact your Zimmer representative or visit us at www.zimmer.com
Lit.No. 06.01600.012 – Ed. 01/2009 ZHUB
+H84406016000121/$090101A09S