DePuy Orthopaedics, a unit of Johnson & Johnson, announced that it was phasing out production of all-metal replacement hips that were beset with high early failure rates. DePuy is just one of a number of manufacturers moving away from using all-metal replacement hips. All-metal replacement hips — in which both the cup and ball of a device are made from metal — are estimated to account for 1 in 3 hip implants in the U.S.
In 2010, DePuy Orthopaedics recalled an all-metal model known as the ASR XL Acetabular System (ASR) because it was failing just a few years after implant. Beginning in 2008, the FDA received approximately 400 complaints from patients who had ASR hip replacements. The 2010 recall came after data from a study indicated that the five-year failure rate of ASR approached 13 percent, or 1 in 8 patients. Artificial hips made from a combination of plastic and metal generally last 15 years or more before replacement of the device is warranted.
Johnson & Johnson is facing approximately 10,000 lawsuits from patients who allege injuries from failures in the all-metal ASR implants sold by the company.
Beyond these failures, replacement of implanted all-metal hip device can be problematic as well, as the procedure can leave behind dangerous, possibly deadly fragments that may not be discovered for years. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, and tissue damage or muscle damage. After the ASR recall, DePuy continued to sell a different all-metal hip replacement called the Pinnacle.
In its statement announcing the phase out, DePuy noted the sharply declining demand for the all-metal devices coupled with a recent proposed rule by the FDA regarding all-metal devices. The FDA proposed rule would require all metal-on-metal hip replacements with existing 510(k) clearances to be
approved through the premarket approval (PMA) process. Sales of all-metal components used in the hip replacement systems are expected to end in August.