DePuy, J&J Issue Recall on Adept Metal-on-Metal Hip Implant Due to High Early Failure RateFeb 19, 2013
While it subsidiary fights continues to fight claims that one of its metal-on-metal hip implants is defective and responsible for thousands of injuries, Johnson & Johnson has issued a recall on another similar device it sells internationally.
According to a New York Daily News report, the healthcare giant has issued a recall on its DePuy Orthopaedics Adept brand metal-on-metal hip implant. This recall comes amid numerous reports that this artificial joint has caused recipients to suffer serious injuries, including pain and inflammation and the need for recipients to undergo early revision surgeries to replace the device.
The announcement comes more than two years after the company recalled its much-maligned ASR metal-on-metal hip implant from the global market. For that device, more than 10,000 recipients have filed claims in courts across the country that allege the company knew it was defective but continued to market it as safe and effective for years. Currently in Los Angeles Superior Court, the company is facing the first of what could be thousands of trials involving a victim of the device who claims to have been injured by the defects and flaws in its design.
The problems with the Adept brand of metal-on-metal hip implant mirror those of the ASR device, which was recalled in August 2010 amid thousands of reports of complications suffered by recipients. For Adept, mounting reports of problems with severe pain, inflammation, the amount of early failures that led recipients back to the surgeon for a revision procedure to remove the device led to this recall.
New York Daily News adds that the recall on Adept only concerns the cup component of the device, not its femoral neck part. This implant, like others, is made of two metal components. DePuy marketed the Adept device in Germany and in 20 other countries around the world but not in the U.S. Based on information compiled by a British medical device database, the Adept device has been linked to a very high early failure rate, at 12 percent. In the first seven years of wearing this device, at least that many recipients can expect to experience complications consistent with a failed hip implant: pain, inflammation, and loosening of the implant.
Johnson & Johnson said that it has recalled all 7,500 Adept implants it sold between 2004 and 2011. The company is currently involved in aggressively defending its safety record regarding metal-on-metal hip implants like Adept as a trial involving one of its most popular devices, the ASR hip implant, is the subject of more than 10,000 lawsuits in the U.S.
In that Los Angeles trial, a former Montana prison guard claims his ASR hip implant failed early and caused him to suffer serious injuries that led to him having the device removed. He also claims the metal-on-metal hip implant caused him to develop dangerous accumulations of toxic metals cobalt and chromium in his bloodstream that caused organ and tissue damage internally.
DePuy claims that it properly tested that device and maintains its recall action was not for safety precautions but due to a disappointing “clinical standard” established by the ASR hip implant.