FDA Executive Summary Memorandum

Metal-on-Metal Hip Implant Systems

Prepared for the June 27-28, 2012 Meeting of the

Orthopaedic and Rehabilitation Devices Advisory Panel

Gaithersburg Hilton

Gaithersburg, Maryland

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309302.pdf.

I. Introduction and Purpose of Advisory Panel Meeting

Hip arthroplasty devices, including metal-on-metal (MoM) hip systems, have been available and in use within the United States for over 50 years.  They are frequently used to relieve pain and restore joint function in patients with chronic hip pain or disease which is not responsive to more conservative therapy.

All told over 400,000 hip arthroplasty procedures are performed in the United States on an annual basis (Appendix A).

With widespread use of these MoM hip systems, more information has become available regarding clinical performance as well as adverse events.  Recent data from orthopaedic implant registries as well as peer-reviewed journal publications and presentations at scientific meetings have suggested increases in potential safety issues associated with MoM hip systems including:

1. Local complications such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions (“ALVAL”);
2. Early device failure and the need for revision surgery; and
3. Systemic complications from metal ion exposure.

FDA believes that in keeping with its public health mission, it is appropriate to have an open and transparent dialogue among manufacturers, physicians, researchers, the public, and FDA to review currently available data regarding MoM hip systems in an effort to better characterize any potential and real safety risks and generate scientifically-based recommendations for the clinical and patient communities on how to best communicate and mitigate them.

This Advisory Panel meeting is not intended to: (1) reassess the original market entry data; (2) discuss the current or future classification of MoM hip systems; or (3) discuss mandated postmarket studies (i.e., “Section 522” or “post-approval” studies) currently underway for MoM hip systems.

Download full paper here: FDA Executive Summary Metal-on-Metal Hip Implant Systems Prepared for the June 27 – 28 2012 Meeting

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