Since the recent Order for Post market Surveillance, requiring all Metal on Metal Manufacturers to monitor the effectiveness of their hip replacement and resurfacing systems, the FDA has begun their own review on metal on metal hip implant system data.
The FDA is working with a number of partners, domestically and internationally, to understand why certain hip implant systems are failing, and if there are any related signs and symptoms. In addition to working with the manufacturers to review device retrieval analyses, the FDA is reviewing published Medical Device Reports including Adverse Event Reports, and post approval studies for the following data.
- Comparison of Risk-Benefit Analysis
- Utilization Trends
- Patient Selection Criteria
- Pre-operative counseling for the patient
- Follow up counseling and care
- Revision Rates
The Chief complaint for some of the major metal on metal hip implant manufacturers, including DePuy, Biomet & Wright have been a high early failure rate resulting in high revision rates.