After the DePuy ASR hip recall of August 2010, many concerned patients are wondering whether a DePuy Pinnacle hip recall for the all-metal version of that device has also been issued. The two metal hip replacement systems allegedly share similar design defects, which can cause adverse reactions and early hip replacement failure. Metal debris can shed from the hip implants and cause side effects such as pain, inflammation, tissue damage, metallosis (high levels of toxic cobalt and chromium in the blood stream) and more. Given the similar risks from the two devices, it seems likely that a DePuy Pinnacle recall would be issued as well.
Johnson & Johnson issued a voluntary recall of the DePuy ASR XL Acetabular System, a total hip resurfacing system, and the ASR Hip Resurfacing System, a partial hip replacement intended to preserve the bone, in 2010. The ASR hip recall affected 93,000 devices worldwide, and has spurred thousands of lawsuits from patients who received defective ASR hip implants and suffered side effects.
The ASR hip systems were approved in 2005, through the U.S. Food and Drug Administration’s expedited 501(k) process, which allowed it to go to market without clinical testing because it was deemed similar enough to a predicate device. It’s no wonder that subsequent data revealed unacceptably high failure rates. DePuy issued the recall after data from a joint registry in England showed that approximately 12 percent of patients who received an ASR implant needed revision surgery. Data from a May 2011 Bloomberg News article revealed that the DePuy ASR hip failed in the U.K. as often as 49 percent of the time. About 74 percent of the 12,137 adverse events reported to the FDA in 2011 involved the DePuy ASR hip implant.
Like the DePuy ASR hip implant, one version of the DePuy Pinnacle system is a metal-on-metal total hip replacement system manufactured by DePuy Orthopaedics that was also approved through the FDA’s 510(k) process.
The DePuy Pinnacle metal hip implant was marketed to increase mobility while reducing pain in patients with damaged hip joints, and was a predecessor to the DePuy ASR hip implant. However, patients who received DePuy Pinnacle hip implants are allegedly experiencing many of the same complications associated with the recalled ASR hip system. Many have been forced to undergo painful revision surgery. Despite its dangers, no DePuy Pinnacle hip recall has been issued, and the device remains on the market.
Victims of defective Pinnacle hip implants are taking action and filing DePuy Pinnacle lawsuits to seek justice and compensation for their injuries. Over 3,000 Pinnacle hip lawsuits have been filed in federal courts, and are currently underway in the U.S. District Court for the Northern District of Texas. If you received a DePuy Pinnacle hip implant and experienced complications, consider joining the thousands of other patients who are filing lawsuits to seek compensation for your medical expenses, lost wages, pain and suffering, and more. Call for a free case review.