In August of 2010, DePuy, a Johnson & Johnson company, announced a global hip replacement recall of two devices: the ASR Hip Resurfacing System and the ASR XL Acetabular System. Data from a recent study concerning XL Acetabular metal-on-metal hip replacement system showed that the 5 year failure rate of the product is approximately 13%, or 1 in 8 patients. It has identified component loosening, component malalignment, fracture of the bone, dislocation, infection, metal sensitivity and pain as the reasons for the failure of the hip replacement system.
Recently, it has been thought that DePuy’s other metal-on-metal implant line, the Pinnacle system (Pinnacle Acetabular Cup System), might also have significant design defects. As of now, DePuy has not issued a voluntary recall on the Pinnacle system, but there are concerns that the Pinnacle system also has an increased failure rate. In 2010, the FDA Adverse Event Reporting System received over 500 complaints from people who had experienced adverse effects from the Pinnacle system. Similar to the ASR XL Acetabular and ASR Hip Resurfacing Systems, the DePuy Pinnacle Acetabular Cup System was fast-tracked through the FDA’s medical device approval process because it was similar to already-approved devices.
While over 100 lawsuits have been filed as a result of the DePuy ASR recalls, a small number of suits alleging fault with the DePuy Pinnacle system have also been filed. According to one suit, filed in December 2010, in the U.S. District Court for the Western District of Washington, the plaintiff has undergone six surgeries as a result of metal poisoning he developed after receiving a Pinnacle hip implant in 2007. A second suit, filed in November 2010, in the U.S. District Court for the Central District of California alleges that another plaintiff has been suffering from an abnormal gait, nerve pain and other problems since receiving the Pinnacle device in 2004.