DePuy Orthopaedics, a division of Johnson & Johnson issued a worldwide recall of all components for its ASR™ XL Acetabular System (total hip implant) an DePuy ASR™ Hip Resurfacing Platform. The recall reaches back to all such devices implanted since 2003. The FDA has received hundreds of complaints from patients with swelling, pain, mobility problems, and other serious symptoms, many of which have led to revision surgery. Decades of data shows that only about 10% of people with problems caused by prescription drugs or medical devices actually register complaints with the FDA.
DePuy acknowledges that data indicates that 13% of patients who’ve received the Acetabular (total hip) system needed corrective or revision surgery within 5 years of implantation. Twelve per cent of people implanted with the hip resurfacing system require corrective surgery within 5 years. The problem with these metal-on-metal implants appears to be that they generate metal debris from wear, causing infalmmation and tissue damage in some patients.
Individual cases filed in federal court will be consolidated by the Multi-District Litigation (MDL) Panel with one federal judge who will oversee the discovery process for all such cases. The MDL panel is meeting in Durham, NC in November and will assign the DePuy MDL to a federal judge at that time.