Bad News Mounts for DePuy's Metal-on-Metal Pinnacle Hip ImplantMar 1, 2012 | Parker Waichman LLP
A metal-on-metal version of DePuy Orthopaedic's Pinnacle hip implant system may come under more scrutiny, in the wake of a British Medical Journal investigation that raised questions about the safety of the entire class of all-metal hip implant devices. According to the report, evidence pointing to possible dangers associated with the metal-on-metal Pinnacle hip replacement device was available and known to DePuy Orthopaedics several years ago, yet the company continued to aggressively market the implant
DePuy, a division of Johnson & Johnson, recalled the ASR Hip Resurfacing System and the ASR Acetabular Hip Implant System – both all-metal devices – because of an unusually high premature failure rate. According to the British Medical Journal, internal company emails show DePuy then promoted the Pinnacle as an alternative to the recalled ASR devices.
Among the recommendations given to patients with the recalled ASR implant was advice to have their blood tested for dangerously high levels of metal ions. Since then, it's been recognized that metal-on-metal hip implants can shed metal ions into the blood stream. This can cause localized damage to tissue and bones, which can lead the implant to fail prematurely. The ions can also make their way into the blood stream, and possibly put patients at risk of serious, long-term health problems.
So it would seem odd that DePuy would proffer the metal-on-metal version of the Pinnacle implant as an alternative to the ASR device, considering that, according to the British Medical Journal, data showing raised metal ions in people with the Pinnacle device have been available in the medical literature since 2008. According to the report, DePuy even heard from Japanese surgeons in 2009 that they had observed “generated metal debris between stem taper and head, and final necrosed tissue” in people with the metal-on-metal Pinnacle hip replacement.
Unlike the ASR hip implant devices, the all-metal Pinnacle hip replacement has never been recalled. In fact, it has been used in more people than the recalled hip implants. According to the British Medical Journal, the metal-on-metal Pinnacle has been implanted in over 300, 000 worldwide. Roughly 93,000 ASR hip implant devices were used globally by the time they were recalled.
Since the ASR hip implant recall, concerns about the all-metal Pinnacle hip implant have only grown. According to the British Medical Journal, a senior DePuy executive said in a 2010 internal document that he was “concerned” about problems with the metal-on-metal Pinnacle and similar implants. “I feel the problem is emerging as more serious than first thought,” he wrote.
Last year, Tony Nargol, a consultant surgeon at the University Hospital of North Tees, warned British health regulators about potential problems with the DePuy Pinnacle all-metal system. According to a report from the BBC, his hospital tested 970 people with the all-metal Pinnacle hip implant, and found 75 failures related to metal debris, a number Nargol characterized as “really quite high."