Health care giant, Johnson & Johnson just issued another hip implant device recall. The recall of its Adept brand all-metal total hip replacement devices comes just over two years after its DePuy ASR metal-on-metal device was globally recalled and in the midst of the first of 10,000 lawsuits the device maker faces over that failed device.
A spokeswoman for Johnson &Johnson’s DePuy Orthopaedics unit said that the company recalled its Adept all-metal total hip replacement system due to higher-than-expected revision surgery rates, said The New York Daily News. The recall became effective last month and involves the top half of the hip replacement system; specifically, the ball at the top of the thighbone, which fits into the socket of the hip. This worldwide recall involves all 7,500 of its Adept implants that were globally shipped from 2004 through September 2011, said The News.
Johnson & Johnson said the implants were sold to 21 countries, but not in the United States, and had advised surgeons and hospitals about the recall on January 14, said The News. The recall was implemented after the device maker reviewed data from national registries on joint replacement devices in two countries
The Adept is similar to the DePuy ASR, another metal-on-metal hip implant device. As we’ve written, the DePuy ASR was touted, like all other metal-on-metal hip implants, as being more durable and longer lasting than previous hip implant models. This led to some 93,000 ASR hip implants being recalled globally in August 2010. The DePuy ASR implant was available in the U.S. since 2005, when it was approved by the U.S. Food and Drug Administration (FDA).
The first of 10,000 lawsuits over the faultily ASR was brought by a former prison guard who underwent revision surgery to remove the device and alleges the device led to his suffering from dangerously high blood chromium and cobalt ion levels. Loren Kransky’s attorneys told jurors that black pieces of metal flaked off the ASR and led to a metal poisoning that could have killed Kransky had the device not been removed, said The News. An attorney for the device maker denies those claims and sites Kransky’s pre-existing medical conditions as the culprit.
During its time on the market, more and more recipients began experiencing a wide range of complications that were clearly linked to the now-recalled ASR hip implant. Severe pain and inflammation, caused by and resulting from a loosening of the implant, combined with accumulating metallic ions caused by the coming together of the device’s all-metal components, forced many recipients to undergo unexpected medical treatments and eventual revision surgeries to remove the devices.
The News noted that Johnson & Johnson, the world’s largest provider of health care products, has issued more than 30 product recalls since 2009. In addition to these all-metal hip implant devices, recalls have involved nonprescription medicines, such as adult and children’s Tylenol and Motrin; prescription drugs for epilepsy; and even contact lenses. Reasons have ranged from inappropriate active ingredient levels, glass or metal shards in liquid medicines, and foul odors, said The News.