DePuy ASR Hip Implant Recall

DePuy Orthopaedics announced in August 2010 that it is voluntarily recalling its ASR Hip Replacement System used in hip replacement surgery due to the number of patients who required a second hip replacement procedure, called “revision surgery.”

New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12 percent for the hip resurfacing system and approximately 13 percent for the acetabular system.

Kevin J. Bozic, MD, an orthopaedic surgeon and vice chair of orthopaedics at the University of California at San Francisco Medical Center, who has studied revision rates in hip replacement, noted in a report published in Arthritis Today that the failure rate for the DePuy ASR hip replacement appears to be about twice the industry average.

“It was a design failure that frankly wasn’t picked up until they were implanted in thousands of patients,” Dr. Bozic says.

Women At Greatest Risk

While second surgeries were required across the entire size range of hips replaced, DePuy notes the risk for revision was highest with ASR head sizes below 50 mm in diameter, and this affects mostly female patients.

DePuy claims earlier post-market observation data from a variety of sources had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.

“We regret that this recall will be concerning for patients, their family members and surgeons,” said David Floyd, president, DePuy Orthopaedics. “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.”

Reported Symptoms

Symptoms included pain, swelling and problems walking. These symptoms are normal if you have just had a hip replacement. But, if the symptoms continue or come back, it is a sign that there may be a problem.

The symptoms might be caused by problems such as:

  • loosening, where the implant does not stay attached to the bone in the correct position;
  • a fracture, where the bone around the implant may have broken; and
  • dislocation, where the two parts of the implant that move against each other are no longer aligned.

The replacement hip is made up of ball-and-socket components that move against each other. These metal components wear over time and generate very small, microscopic particles that can only be seen with a microscope. The DePuy site notes this is an expected process in a hip replacement.

In some patients, however, the particles may react, causing fluid to collect in the joint and in the muscles around the joint. This may eventually result in pain and swelling around the joint and could damage some of the muscles, bones and nerves around the hip.

Class Action Filed

A DePuy ASR hip recall class action lawsuit has been filed on behalf of all individuals who received the defective device.

The complaint was filed on September 24 in the U.S. District Court for the Southern District of Ohio, by plaintiffs Katheryn and Jonathan Bendel. The lawsuit seeks class action status to represent any individuals in the United States who received a DePuy ASR hip replacement, as well as their spouse. The class certification is pending.

If you have had a DePuy ASR hip replacement, you should speak with an attorney experienced in handling defective medical devices. He or she can examine your situation and help you decide if litigation may be necessary to protect your rights and your health.