DePuy Metal-on-Metal Hip Recall Issued Outside U.S. Due to Failure Rate
Problems involving high failure rates with yet another DePuy metal-on-metal hip replacement have caused Johnson & Johnson to issue a recall for more than 7,500 implants sold outside the United States, coming more than two years after the manufacturer issued a DePuy ASR metal-on-metal hip recall following similar issues that surfaced in August 2010.
According to information sent to Germany’s Federal Institute for Drugs and Medical Devices, Johnson & Johnson’s DePuy Orthopaedics subsidiary disclosed last month that it was issuing a recall for the DePuy Adept implant, warning doctors that the modular heads of the artificial hip system should not be used.
The DePuy Adept hip recall was issued after an analysis of data from a British hip implant registry indicated the implant failure rate was about 12% within seven years.
The recalled DePuy Adept hip implants were sold in at least 21 countries worldwide, but not the United States. The hip implants were on the market from 2004 through September 2011.
DePuy ASR Hip Recall Lawsuits in U.S.
The decision to remove the DePuy hip implant from the market comes as manufacturer faces thousands of lawsuits over the recalled DePuy ASR hip, which is another metal-on-metal implant that was removed from the market amid reports of higher-than-expected failure rates associated with debris that may be shed into the body as the metal parts rub against each other over time.
Johnson & Johnson announced the DePuy ASR metal hip recall in August 2010, again pointed to British hip implant registry data that found a 12 to 13% failure rate associated with the device.
The first DePuy ASR trial is currently underway in California state court, with a number of former Johnson & Johnson employees and other witnesses providing testimony that suggests the manufacturer knew about the risk of problems with metal-on-metal hips long before they issued the ASR recall. Some internal documents offered during the trial have suggested that the company’s own predictions estimated a failure rate may reach as high as 37%.
The DePuy Adept hip resurfacing and total hip system also features a metal-on-metal design, with a metal ball at the top of the thigh bone that fits within a metal hip socket. The recall only impacts the ball portion of the implant.
Metal-on-Metal Hip Problems Not Limited to ASR and Adept
In addition to lawsuits over the DePuy ASR, other metal-on-metal hip designs have been the focus on large numbers of complaints, including the DePuy Pinnacle hip, Biomet M2A Magnum hip and Wright Medical Conserve Cup.
In January, the FDA released new guidance for metal-on-metal hip replacements. The agency told doctors that metal-on-metal hip replacement systems should only be used if other artificial hip implants were not appropriate, and called on manufacturers to prove that their implants were safe enough to stay on the market. Future metal-on-metal hip designs will have to undergo extensive human clinical trials before being made available for sale, the FDA decreed.