DePuy Recalls Faulty Custom Joint Implants
DePuy Joint Implants Not FDA Approved
According to the U.S. Food and Drug Administration (FDA), the customized joint implants were being sold without federal approval. While DePuy argues that the implants already received approval and are modified to fit consumers, the FDA says clinical trials and a marketing submission are still required. According to drugwatch.com, despite customized shapes and sizes, the joints’ design characteristics do not change and require FDA approval.
ASR Hip Implant Recall
DePuy Orthopaedics also recalled 93,000 defective ASR hip-replacement and resurfacing devices in 2010 after they were shown to fail after a few years. The defective artificial hips have also been shown to produce metal shavings that can cause blood poisoning, increasing risk of bladder and kidney cancer, according to drugwatch.com.
Recalled Hip Implants
- Two years after the ASR hip-implant recall, DePuy is recalling over 8,300 customized joint implants.
- More than 8,000 lawsuits have been filed against DePuy over hip implants, 6,000 of which are part of a multidistrict litigation (MDL).
- DePuy stopped manufacturing the implants after a warning from the FDA in January 2012 and issued the recall in August 2012.
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