DePuy ASR hip implant failure continues to haunt DePuy Orthopaedics and Johnson and Johnson Inc.  The device was first approved without full clinical trials through the Food and Drug Administration’s (FDA) 510(k) program in 2005.

The FDA reports receiving up to 400 complaints about the functioning of the hip prosthesis from recipients since 2008.

In March of 2010, Johnson and Johnson – parent company to DePuy Orthopaedics – was forced to admit that DePuy ASR hip implant failure occurred in about 12% of hip arthroscopies. This DePuy hip implant failure led to another necessary surgery known as the hip revision.

While hip revisions often involve the replacement of only one part of a prosthesis after a significant amount of time has elapsed, revisions in these cases required the total removal of the prosthetic device and the implantation of a replacement unit.

A voluntary recall was initiated by the DePuy company, but only a year and a half after the first lawsuit over a DePuy ASR hip implant failure came to court. In August of 2010, five years after it was allowed onto the market, both ASR models were recalled.

Experts hotly debated why it took the company as long as it did to take this definitive action with such a high rate of post-surgical issues.

DePuy ASR hip prosthetic implants are metal-on-metal products. The FDA has received numerous complaints about metal-on-metal prosthetic units in general.

The agency has received several thousand adverse medical event reports about DePuy ASR units. Some of the rapid increase in reporting could have been attributed to the voluntary recall issued the prior year.

DePuy ASR Hip Implant Failure Issues

Problems with metal-on-metal knee or hip prosthesis units have been linked to corrosion and the leaching of metal debris into surrounding tissues and the blood.

Often, a blood test for elevated levels of chromium or cobalt has revealed a medical situation known as metallosis where there is an accumulation of such debris around the area of an implant. Metallosis can cause a hypersensitivity in the area causing masses or pseudotumors to develop.

What may also occur during a DePuy ASR implant failure is bone loss. Bone cells and tissues are worn down and not replaced as quickly as they are destroyed. This is known as osteolysis.

Symptoms of DePuy ASR hip implant failure may include:

• Severe pain
• Swelling
• Infection
• Metal Sensitivity
• Dislocation or even fracture
• Loosening of prosthesis

Several hip implant lawsuits against DePuy Orthopaedics and Johnson and Johnson Inc. have been looped into a multidistrict litigation (MDL) to be processed in U.S. District Court in the Northern District of Ohio. The MDL is identified as No. 2197.

It is expected that since there were over 93,000 recipients of the DePuy ASR hip implants globally, the related companies will suffer financial losses over litigation now and for several years to come.