DePuy Orthopaedics’ ASR hip replacement has been linked to an increased risk of complications and failure versus other hip replacements requiring many people to undergo painful and costly replacement surgeries to remove defective hip implants. The metal-on-metal device has caused increased pain and limited mobility, despite the device being marketed to do just the opposite.
Many concerns about the ASR hip replacement stem from the implant’s metal composition, including cobalt and chromium, which can be dangerous and carcinogenic. Small pieces of the hazardous metal have been known to grind off the ASR hip implant and enter the bloodstream causing intense leg, hip, and groin pain. These metal shavings trigger pain and inflammation of the surrounding tissues and muscles, which can cause immobility and produce muscle necrosis, an irreversible condition. Moreover, design flaws also have been found in the Depuy ASR hip replacement, leading to fractures, implant dislocations, friction transfer to the pelvis, and ill- fitting implants.
At least 12% of patients who have had an ASR hip implant surgery have been required to undergo a risky secondary surgery to replace the defective hip. It is likely that number will increase as more ASR hip implants fail over time. Surgery to replace the defective hip is costly ranging from $50,000 to $100,000, not to mention the extensive post-procedure rehabilitation, which is an additional cost.
It took hundreds of patient complaints, injuries and failures over several years before DePuy decided to finally disclose the failures of the ASR hip replacement to physicians and patients. As a result of the defect, two DePuy hip replacement devices, the ASR Hip Resurfacing System and the ASR XL Acetabular System were finally recalled in 2010. That same year, after patient complaints of safety and proof of failure, Depuy acknowledged data that showed a 12% failure rate in the ASR Hip Resurfacing System and a 13% failure rate in the ASR XL Acetabular System. Additionally, women have had a higher rate of failure than men, and it is reported that women with smaller hip implant systems of 50mm have been the most seriously affected.
Currently, the FDA has received thousands of complaints about all-metal hip replacements, and more than 75% of these involve Depuy’s parent company Johnson & Johnson. While the ASR failure rate was at 12 to 15% in the first two years, it dramatically increased to 49% at six years post-implementation, confirming the serious defects related to the ASR hip.