DePuy ASR and Pinnacle Hip Replacement Devices

There have been hundreds of lawsuits across the country due to premature failure of the DePuy ASR and Pinnacle metal-on-metal hip replacement devices.

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Premature failures of the DePuy ASR and Pinnacle metal-on-metal hip replacement devices have led to lawsuits across the country. These devices, which typically should last 15 years or more, have been failing within a couple years after implantation in many patients. Hundreds of lawsuits have alleged that these medical devices had design and manufacturing defects that led to disturbing rates of failure, requiring additional revision surgeries. Among the failures, patients reported symptoms of severe pain, swelling, and loss of mobility, which are signs that the implant could be loosening in the socket, fracturing, or dislocating. Some hip replacement devices have also been associated with metallosis.

On August 26, 2010, the ASR™ XL Acetabular Hip Systems and DePuy ASR™ Hip Resurfacing Systems were recalled by Johnson & Johnson’s subsidiary, DePuy Orthopaedics. And while DePuy’s all-metal Pinnacle® Acetabular Cup System has not yet been recalled, on May 6, 2011, the FDA issued a post-market surveillance study of all metal-on-metal hip replacement devices, requiring manufacturers to monitor adverse events of their devices, and the FDA continues to receive hundreds of adverse event reports related to Pinnacle.

The most recent ASR recall is based on premature failure of the device. According to reports, approximately 13 percent of patients who had total hip replacement surgery with an ASR hip device needed to have replacement surgery within five years. In addition, according to DePuy, there were about 93,000 hip metal-on-metal hip implants included in the recall.

More recently, following DePuy’s recall of its ASR hip devices, the Eight Annual Report 2011 of the National Joint Registry for England and Wales reported that the DePuy ASR had the highest failure rate of all metal-on-metal hips, with a 29% failure rate for patients who were implanted with the ASR six years ago. Part of the concern for this high failure rate is that defective metal-on-metal hip implants cause metal toxicity or metalosis. The New York Times recently reported that these devices can also cause tissue and muscle damage as a result of metal poisoning.

The ASR hip is made up of cobalt chrome ball and socket components that move against each other. Over time, the cobalt chrome material breaks down and microscopic particles are absorbed into the body. This metal ion release can damage tissue, muscles, bones, and nerves around the hip. It can result in psuedotumors, and osteolysis, leading to hip revision surgery to remove and replace the implant.

DePuy is recommending that all patients with an ASR hip, implanted after 2003, contact their surgeons immediately, even if they have no symptoms. They should participate in a series of tests to determine whether their implant is at risk for failure, and in need of replacement. These tests include blood tests and radiology to see if any of the chrome particles are present in the body.

DePuy hip implant patients may be eligible for compensation due to injuries they have suffered as result of the failed hip implant, lost earnings, disfigurement, and out of pocket expenses. At Pogust Braslow & Millrood, protecting our clients is our primary goal. We recognize that drug companies are under an obligation to warn about the known risks of their products. When they fail to do so, they may be held responsible for the injuries or deaths that are the consequence of their inaction.

If you or a loved one has suffered complications as a result of a DePuy ASR Hip Replacement System, you should immediately contact the attorneys at Pogust Braslow & Millrood, where Protecting Patients Is Our Primary Goal.