DePuy Orthopaedics is being forced to recall yet another line of hip and other artificial joint implants. This time, the Johnson & Johnson subsidiary said that it would be pulling all of its unused custom orthopedic devices due to concerns raised by the FDA. The recall notice was issued on August 24, 2012, two years after the company issued its major ASR hip-implant recall.
Earlier this year DePuy agreed to stop manufacturing the custom devices after receiving a warning letter from the FDA. The regulatory agency said the implants had not been through clinical trials and were thus being sold without federal approval. DePuy argued that the devices were exempt from the normal application process given that the FDA had approved the original devices and the custom pieces were only being modified.
The FDA disagreed and wrote that, “Although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured.” The agency said that the fact that the final specifications may differ depending on the recipient does not mean that DePuy was excused from the usual FDA approval process.
The FDA went on to accuse DePuy of using poor quality control systems in the production of the different custom implants and ordered the company to recall any implants that had already been delivered to surgeons. Though more than 8,300 customized DePuy implants have been sold since 1999, the exact number of unused devices subject to this recall is unknown.
The news comes at a bad time for the medical device maker as DePuy is dealing with the huge global recall of 93,000 ASR hip-replacement and hip-resurfacing devices that was announced in August of 2010. The all-metal devices have been shown to fail within only a few years’ time, leading to painful and costly revision surgeries. Beyond the need for additional surgery, the DePuy hips have also caused metallosis due to the release of metal shavings created when the parts rub together. Some studies have shown that these metal pieces can cause damage to patient’s bladders and kidneys.
The ASR recall has precipitated a flood of lawsuits against the company. In the U.S. alone, more than 8,000 lawsuits have been filed against DePuy, with the first cases finally making their way to a settlement.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please call contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.
Source: “FDA asks J&J’s DePuy to recall unused custom implants,” by Josh Sandberg, published at OrthoSpineNews.com.