Sei sulla pagina 1di 2

Knees Hi ps Extremi ti es Cement and Accessori es PMI

Trauma Technol ogy


Design Affects Performance of Metal-on-Metal Constructs
Well designed metal-on-metal (MoM) hips are good
options for many patients. However, design features
in certain MoM components have lead to increased
failure rates.
1,2
Biomets M
2
a-Magnum

System
delivers a clinically proven, unique design that has
shown a statistically signicant lower revision rate
than other MoM implants.*
*M
2
a-Magnum

System
Lowest cobalt ion levels in a peer-reviewed,
head-to-head study of four MoM implant
designs
3

Over 98% median reported survivorship at
three years
414
In over 10,000 cases, revision rate is less
than 2.5%
421
Similar revision rate to metal-on-poly in
the Australian and New Zealand NJR
(2.6% and 2.9%)
22,23

Statistically signifcant lower revision rate
than other MoM constructs in the New
Zealand NJR (3.9%)
23
Feature M
2
a-Magnum

System Other MoM Constructs


Head
Coverage
The M
2
a-Magnum

System provides up to 165 degrees of


acetabular head coverage to help minimize the potential for
edge loading and metal debris.
Insuffcient acetabular head coverage has been linked to
increased metal ion levels, metal debris and metal-on-metal
implant failures.
24,25
Fixation
The M
2
a-Magnum

cup utilizes proven PPS

coating
26
and
four paired sets of fns to enhance initial fxation and rotational
stability.
One peer-reviewed paper of a recalled MoM system links poor
fxation to cup design.
1
Taper Insert
The M
2
a-Magnum

System is the only MoM implant to offer a


titanium insert.
CoCr inserts have been linked to increased cobalt ion levels,
which may be a result of taper junction corrosion
3
Head Design
The titanium taper insert seals the head cavity from organic
debris and leaves no sharp edges to impinge soft tissue
Previously recalled MoM components were designed with an
opened-back head.
2
Clearance
The M
2
a-Magnum

System provides optimal clearance of


150300 microns for fuid flm lubrication
Excessive clearance can lead to point loading and increased
wear. Inadequate clearance can lead to increased wear and
early loosening.
28,29
P.O. Box 587, Warsaw, IN 46581-0587 800.348.9500 x 1501
2011 Biomet Orthopedics biomet.com
Form No. BOI0325.0 REV063011
References
1. Long, W. et al. Failure of the Durom Metasul

Acetabular Component.
Clinical Orthopaedics and Related Research, 468:4005, 2009.
2. DePuy ASR

Systems Urgent Field Safety Notice (March 2010).


3. Lavigne, M. et al. Comparison of Whole-Blood Metal Ion Levels in
Four Types of Metal-on-Metal Large-Diameter Femoral Head Total
Hip Arthroplasty: The Potential Infuence of the Adapter Sleeve.
Journal of Bone and Joint Surgery, 93 Suppl 2:12836, 2011.
4. The England and Wales National Joint Registry (UKNJR) Data
Extract as of March 2011 (DS1)
5. Biomet Magnum Multi-center Study (DS10)
6. Biomet France ReCap/Magnum Study (DS17)
7. Australian national Joint Registry (AOANJRR) Annual report 2010
Metal/Metal Conventional Total Hip Replacement (DS19)
8. Biomet Japan Magnum study (DS21-JP)
9. Biomet Korea Magnum study (DS21-KR)
10. Biomet Taperloc Microplasty Study (DS24)
11. Biomet Ortho Balance Microplasty Study (DS25)
12. Biomet UK Oswestry Magnum Study (DS28)
13. Biomet UK Bristol Magnum Study (DS32)
14. UK Orthopedic Device Evaluation Panel NHS Rating (DSL)
15. M2A Registry Databases - JIS, TRJ & JRIS (DS2)
16. Finnish National Joint Registry Data Extract (DS4)
17. M2A Registry Database JIS (DS7)
18. Biomet Denmark ReCap/C2A/Magnum Study (DS20)
19. Virolainen , P. et al. Early Results of Large Head Metal-on-Metal
Hip Arthroplasties, Oral Presentation at 55th Nordic Orthopaedic
Federation Congress, May 2010 (DS26)
20. Swedish Hip Arthroplasty Register Data Extract (DS29)
21. Australian National Joint Registry (AOANJRR) Annual report 2010
Conventional Total Hip Replacement (DSK)
All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless
otherwise indicated.
This material is intended for the Biomet Sales force and physicians only and is NOT
intended for patient distribution. It is not to be redistributed, duplicated or disclosed
without the express written consent of Biomet.
For product information, including indications, contraindications, warnings, precautions
and potential adverse effects, see the package insert and Biomets website.
22. Australian National Joint Registry Annual Report 2010
23. New Zealand National Joint Registry 10 Years
24. Langton, D. et al. A Review of 585 Serum Metal Ion Results Post
Hip Resurfacing: Cup Design and Position is Critical. Paper No.
006, American Academy of Orthopaedic Surgeons, 2010.
25. Langton, D. et al. The Incidence of Adverse Reactions to Metal
Debris (ARMD) Following Hip Resurfacing. Paper No. 012, American
Academy of Orthopaedic Surgeons, 2010.
26. McLaughlin, J. et al. Total Hip Arthroplasty with an Uncemented
Tapered Femoral Component. Journal of Bone and Joint Surgery,
90:12906, 2008.
27. Johnson & Johnson Gateway ASR XL Product Information, 2007.
28. Dowson, D. et al. A Hip Joint Simulator Study of the Performance
of Metal-on-Metal Joints. Part I: The Role of Materials. Journal of
Arthroplasty. 8(3):11823, 2004.
29. Dowson, D. et al. A Hip Joint Simulator Study of the Performance
of Metal-on-Metal Joints. Part II: The Role of Materials. Journal of
Arthroplasty. 8(3):12430, 2004.

Potrebbero piacerti anche