A man implanted with the DePuy Pinnacle Acetabular System Device, a metal-on-metal hip implant device—is suing both DePuy Orthopaedics and its parent company, Johnson & Johnson, over injuries he alleges were caused by the defective hip replacement system.
The lawsuit was brought in Philadelphia federal court on March 4 on behalf of Mark Hart, said The Federal Register. Hart claims the Pinnacle device caused him serious pain; “a debilitating lack of mobility”; and to undergo serious, complex revision surgery to have the Pinnacle removed and replaced in 2012. Although a third replacement device has been recommended for Hart, he will be unable to undergo this surgery because he lacks sufficient bone structure, The Federal Register noted.
According to the complaint, the metal-on-metal Pinnacle hip prosthesis was designed “for human hip joints” that are “damaged or diseased due to fracture, osteoarthritis, rheumatoid arthritis, and avascular necrosis,” The Federal Register explained. The Pinnacle has been named in more than 1,300 complication or failure reports.
Hart’s complaint alleges that DePuy Orthopaedics and Johnson & Johnson were aware—before August 2010—that use of the Pinnacle device in patients could lead to metallosis, biologic toxicity, and a higher-than-expected failure rate that requires revision surgery to remove and replace the device. In fact, the lawsuit states that the defendants know for two years before the device was recalled in 2010 that their hip devices—including the DePuy ASR XL Total Hip System and ASR Hip Resurfacing System—were likely to fail within about two years of implantation, despite that the devices were touted to last more than 15 years, said The Federal Register.
As we’ve explained, most Pinnacle lawsuits center on the overarching problem seen in many metal-on-metal hip implant devices—a defect that puts recipients at serious risk of permanent injuries such as tissue and organ damage. Like other metal-on-metal hip implants, the DePuy Pinnacle model is prone to disperse tiny metal fragments through normal wear-and-tear of the device, which causes an accumulation of the toxic metals cobalt and chromium in a recipient’s body. Should this issue remain undetected, the patient could be placed at risk for dangerous complications, including pseudo-tumors in the muscle, tissue death, and organ damage.
People who’ve received the Pinnacle hip implant have also reported pain and inflammation at the site of the implant, popping and squeaks from that area, and complete device failure. Although the Pinnacle and other metal-on-metal implants were touted as an option for younger recipients because they’re allegedly designed to last longer than traditional implants, the opposite has proven true.
As we’ve written, following the outcry over the ASR and other all-metal devices, such as the Pinnacle, the U.S. Food and Drug Administration (FDA) is now trying to impose stricter regulations for metal hip makers. The agency has proposed that the devices go through pre-market approval, rather than the fast-tracked 510(k) process; the proposed process would require manufacturers to conduct clinical tests for safety and efficacy before obtaining approval.
According to the complaint, Hart’s injuries will likely cause him to have to be confined to a wheelchair, said The Federal Register.