DePuy ASR Recall Issued After Warning About Hip Replacement Failures

The market withdrawal of the DePuy ASR hip replacement system earlier this year, combined with a warning to physicians about the high failure rate associated with the device, are now being called a DePuy ASR recall by the FDA. 

The FDA indicated on July 17 that the actions of DePuy Orthopaedics, a subsidiary of Johnson and Johnson, in regards to its ASR hip implant were classified as a Class 2 medical implant recall. Specifically, the company’s notification to clinicians of new revision rate information regarding the use of the devices was cited as a reason for the DePuy ASR hip recall.  

The manufacturer initially indicated that their decision to remove the device from the market was not issued due to any safety problems with DePuy ASR hip cups, rather because of low sales numbers. However, on March 6, DePuy sent a letter to doctors indicating that the ASR hip implant has been linked to a high failure rate. Many patients who received DePuy ASR hip replacements have experienced hip failures soon after the device was implanted, leading to additional hip surgeries.

The DePuy hip recall involves 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm.

The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.

Between 2007 and 2009, reports of problems with the DePuy ASR hip began to spike, with nearly 100 recipients reporting problems in 2007, more than 200 reporting problems in 2008, and more than 300 reporting problems in 2009. Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopaedics and found that 3.4 percent suffered from adverse reactions to metal debris. Surgeons are warning that one to three percent of all metal on metal hip implant recipients may experience hip implant problems, and possibly need to have the devices replaced, due to metallic debris.

In recent months, a number of DePuy hip lawsuits over faulty ASR Cup implants have been filed. It is expected that the number of cases will continue to grow as Depuy ASR recall lawyers continue to investigate and review potential cases for individuals who have experienced problems and complications after hip replacement surgery involving the device.