On July 24, 2008, Zimmer Holdings issued a recall of their Total Hip Replacement system with Zimmer Durom Cup Hip Socket Implant. This was just the beginning of a rash of prosthetic metal on metal hip devices that would be subject to recalls and warnings over the next three years. The most notable came in August 2010 when DePuy Orthopaedics issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System.
Zimmer Durom recipients have suffered high early failure rate which has required many to undergo revision surgeries.
Recipients of Depuy’s Total Hip Replacement systems ASR and Pinnacle, have also complained of high early failure rate, in addition to loosening of the device and metal poisoning. Revision surgery is also required for many DePuy recipients.
Patients who received metal on metal hip implant systems from Biomet and Wright have had advised of similar experiences.
In May 2011, almost a year after the DePuy Recall, the FDA issued an order for post-market surveillance to all manufacturers of Metal On Metal Hip Implant systems. In short, the FDA is requiring these manufacturers to monitor the successes and failures of the products and report findings to the FDA. The agency is seeking information on metal ion concentrations and their effects on long-term outcomes.
These metal on metal hip implant manufacturers were given thirty days from receipt of the FDA’s letter to provide their own three-year research plan, which must be submitted to the FDA for approval.
The DePuy recall has left many consumers, doctors and lawyers who are filing suit on behalf of injured implant recipients, to wonder Are Metal on Metal Hip Implants Dangerous? The FDA is hoping that results of the Manufacturers three year study will help them determine if we’re looking at a few design flaws, or if the concept of metal on metal hip joints is unsafe.