DePuy Orthopaedics Inc., a unit of Johnson & Johnson (acquired in 1998) which describes itself as the first commercial orthopedics company in the United States, announced a voluntary recall of two hip replacement products in August 2010. The ASR™ XL Acetabular Hip System (ASR), sold in the United States, and ASR™ Hip Resurfacing System, sold internationally only, were designed to eliminate the problem of the device failing due to overuse. Both products are distinct from the DePuy Pinnacle hip implant.
The ASR recall followed more than two years of ASR failures occurring only a few years after implant (over 300 reports filed with the FDA), much sooner than the instead of the 15 plus years artificial hips are supposed to last, and requiring total hip replacement revision surgery. From August 2005, when the FDA approved the DePuy 510(k) device application, through August 2010, approximately 40,000 patients in the United States received the ASR implant. Although DePuy had notified physicians in March 2010 of a high early failure rate in some patients, the August 2010 recall followed the release of new data from the National Joint Registry of England and Wales indicating the revision rates within 5 years were approximately 13 percent, or one in eight patients.
Both ASR product design features metal on metal construction, which was intended to improve the failure rate of hip implants and an attempt to address problems associated with hips made from traditional materials like metal and plastic. Studies have shown that the designs created more serious problems related to the excessive amount of metallic debris they generated with wear. The debris can cause a severe inflammation reaction, which can lead to tissue and muscle damage that can affect subsequent revision surgery. Hip surgery implant patients reported pain, swelling and difficulty walking and other post surgery complications including:
Additionally, high cobalt levels have been measured in ASR patients. Cobaltism is of special concern in patients with impaired kidney functioning and can result in tinnitus, vertigo, deafness, blindness, optic nerve damage, convulsions, headaches, peripheral neuropathy, cardiomyopathy and hypothyroidism. Approximately
In June 2010, the first U.S. lawsuit against DePuy Orthopaedics was filed. The United States Judicial Panel on Multidistrict Litigation (MDL No. 2197) includes over 8,600 ASR cases to Judge David A. Katz in the U.S. District Court for the Northern District of Ohio. Thousands of additional ASR cases are pending in state courts. A January 2013 trial resulted in an $8.3 million judgment for a hip implant plaintiff. In November 2013, parent company Johnson & Johnson agreed to pay $2.5 billion to settle 7,500 of the ASR cases, which agreement provides a $250,000 base award to U.S. citizens and residents who are more than 180 days from their hip replacement surgery, and prior to August 31, 2013, had to undergo revision surgery to remove the faulty ASR product.