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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Joint Implant Surgery & Research Foundation Chagrin Falls, Ohio, USA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting June 28, 2012 Metal (MoM) Bearings Questions and Discussions An Interview Facilitated by Timothy McTighe Timothy McTighe Dr. HS (hc) Advisory Committee Member: - Executive Director, JISRF - Publisher and Editor-in-Chief Michael B. Mayor, MD for Reconstructive Review, - William N. and Bessie Allyn JISRF Professor of Orthopaedic - Affiliate Member AAHKS Surgery, - Affiliate Member Mid- - The Geisel School of American Orthopaedic Medicine at Dartmouth association - Adjunct Professor of - Affiliate Member Australian Orthopaedic Engineering Association - Michael.B.Mayor@ - Member Orthopaedic Research Society Dartmouth.edu - Member Society of Biomaterials - Member International Society for Technology in Arthroplasty Presenter at Panel Meeting: Timothy McTighe was present on June 28, 2012 Bernard N. Stulberg, MD for the FDA Advisory Committee Meeting on Lutheran Hospital Metal -on- Metal Bearings. As part of the ongoing Cleveland, OH dialogue, JISRF has decided to conduct an interview Professional Societies on this day’s activities and publish this interview in - American Academy of its July edition of the Reconstruct Review. Orthopaedic Surgeons JISRF published an interview on May 31, 2010 on - American Orthopaedic the subject of MoM with eleven surgeons and their Association comments can be viewed at: http://www.jisrf.org/ - American Association of activities/052010.htm Hip and Knee Surgeons - Hip Society As we all know there is considerable debate and - Knee Society concern with the postoperative adverse reactions - International Society for Technology in that we are seeing world wide with the use of MoM Arthroplasty bearings. JISRF has conducted this interview with - Orthopaedic Research and Education six highly respected surgeons and one world class Foundation Tribologist based off the discussions held at the Special Interests recent FDA Device Panel Meeting. Repair of failed or infected joint replacements and complex hip and knee replacements. www.jisrf.org Reconstructive Review • August 2012 77 In Attendance at Panel Meeting: Community Total Joint Surgeons: Thomas K. Donaldson, MD John Keggi, MD Donaldson Research Center Community Orthopaedic Colton, CA Surgeons: Orthopaedics - Private practice since 1991 New England - Board Certified Orthopedic Middlebury, CT Surgeon who has been - Attending Orthopaedic in practice in the Inland Surgeon Empire. - Waterbury Hospital, Affiliations Waterbury, Connecticut - Director and Founder of - New Milford Hospital, DARF New Milford, Connecticut - American Academy of - St. Mary’s Hospital, Waterbury, Connecticut Orthopaedic Surgeons (Courtesy Staff) - American Association of Hip and Knee Surgeons Lou Keppler, MD - Joint Implant Surgery & Research Foundation St. Vincent Charity - American Medical Association Medical Center - San Bernardino County Medical Society Cleveland, OH - Co-Director, The Spine and Ian C. Clarke, PhD Orthopedic Institute - Orthopedic Surgeon Donaldson Research Center - Member JISRF Clinical/ Colton, CA Surgical Advisory Panel - Professor in the Joint and Tissue Sparing Implant Research Center at Loma (TMI™) Study Group Linda University - CO-Director, DARF Ed McPherson, MD - CO-Director of Basic Science, JISRF L.A. Orthopedic Institute - CO-Assistant Editor, Los Angeles, CA Reconstructive Review, - Director of Orthopedic JISRF Surgery - Member JISRF Clinical/ Surgical Advisory Panel and Tissue Sparing Implant (TMI™) Study Group 78 Reconstructive Review • August 2012 www.jisrf.org Joint Implant Surgery & Research Foundation The Original 8 Questions from the FDA to the Advisory Panel: 1. Please summarize the key differences, if any, between US and Outside the United States (OUS) practice which should be taken into account when reviewing/interpreting the data, and which impact the ability to extrapolate OUS data to the US population, including differences in patient population, surgeon experience/preference/technique, and the devices themselves. 2. Based on published registry reports as well as information presented to the Panel today, please discuss the additional data fields which would be appropriate (and practical) to add to existing hip implant registries or include in new registries being developed. 3. For patients who have received a MoM Total Hip Replacement, but are asymptomatic please discuss the optimal follow-up regimen (s) based on current available information. 4. For patients who have received a MoM Total Hip Replacement, but are symptomatic please discuss the optimal follow-up regimen (s) based on current available information. 5. For patients who have received a MoM Total Hip Resurfacing System, but are asymptomatic please discuss the optimal follow-up regimen (s) based on current available information. 6. For patients who have received a MoM Total Hip Resurfacing System, but are symptomatic please discuss the optimal follow-up regimen (s) based on current available information. 7. For patients being considered for primary hip arthroplasty, please discuss: a. Patient or population characteristics which are more likely to achieve the most favorable outcome and/or for whom the risks most likely outweigh potential benefits with a i. MoM THR System ii. MoM Resurfacing System b. Pre-operative laboratory or imaging tests which should be considered in identifying appropriate candidates for MoM THR/ MoM Resurfacing System. 8. Please discuss the key information which should be conveyed to physicians and/or patients as part of product labeling for MoM hip systems, including a. Contraindications b. Warnings c. Precautions d. Directions for Use e. Outcomes Data f. Other The following is going to be a brief review of the historical development of metal on metal bearings so we might better understand how and why we ended up in our current situation. Remember those that don’t remember the past often are doomed to repeat it. www.jisrf.org Reconstructive Review • August 2012 79 Historical Review of MoM Bearings experiments to show that the McKee joint had a high frictional torque in the laboratory and he 1930’s Phillip Wiles from the UK predicted that this frictional torque would eventually designed and inserted the first loosen the fixation of the McKee components in THA. Prior to this date, prosthetic their bony bed. replacement surgery was of the hemi-arthroplasty type with only He was convinced that the natural one arthritic surface being replaced elastohydrodynamic lubrication with synovial fluid and the results were unsatisfactory. could not be used to reduce the frictional torque of the metal on metal articulation and he began his George Kenneth McKee search for self lubricating bearings. GK McKee was a trainee This search took with Wiles and following his him into the field appointment as Orthopaedic of polymers and Surgeon in Norwich, England, his first attempt at began development of total hip hip arthroplasty in replacement the early 1950’s designs. He was a Teflon on developed various uncemented Teflon bearing used Sivash Stem 1960s SRN Stem 1970s prototype total hip replacements as a resurfacing in the 1940’s and 1950’s. McKee for the arthritic femoral head and acetabulum. presented his results to the BOA meeting in Unfortunately the Teflon on Teflon bearings wore Cambridge in 1951. The results in those early days out within two years. were initial relief of pain followed by loosening and mechanical failure. Haboush introduced The Sivash hip was the first C.C. head with a polymethylmethacrylate for fixation of hip titanium stem “constrained socket”. endoprosthesis in 1953 and Charnley popularized ® this use of bone cement. McKee’s cement fixed Eventually lead to the development of the S-Rom McKee-Farrar THR from 1960 was the first Stem System. widely used and successful THR. This THR had a Thompson stem, a chrome cobalt metal on metal Derek McMinn FRCS articulation and both the acetabular and femoral components were fixed with cement. Dr. Derek McMinn qualified from St. Thomas’s Hospital in London. Practicing as a Consultant Orthopaedic Peter Ring Surgeon since 1988, his special interest Peter Ring from Redhill, has been joint reconstruction surgery. Surrey, provided the He always loved taking on the next development in hip challenge of patients with complex hip arthroplasty. He distrusted and knee problems - complexities that often bone cement and developed demanded improvisation and innovation. a self locking total hip The stemmed reconstruction acetabular cup replacement for uncemented for the grossly deficient socket is one of his fixation. innovations. Professor Sir John Charnley His pioneering of the Birmingham Hip Resurfacing has revolutionized the management of hip arthritis Professor Sir John Charnley was in young active patients. In addition to his busy convinced that the metal on metal private practice, he works part-time in the UK articulation of the McKee joint National Health Service at the Royal Orthopaedic was unsatisfactory. He performed Hospital, Birmingham. 80 Reconstructive Review • August 2012 www.jisrf.org Joint Implant Surgery & Research Foundation MoM Interrogatories by McTighe published results, demonstrating the importance of technique and patient selection. In the population Question 1 I selected they have worked well, despite the fact that the instrumentation for the early patients was This was a significant challenge by FDA to rudimentary. Currently I do not perform
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