Defective DePuy ASR XL Acetabular and ASR Hip Resurfacing Systems

Both Systems Have a High Rate of Revision Surgery within Five Years of Hip Replacement

Due to design defects, many patients receiving either the DePuy ASR™ XL Acetabular System or ASR™ Hip Resurfacing Platform found themselves back under the knife within five years of the initial surgery. In the United States, only the ASR XL Acetabular System was approved for use in hip replacement surgeries. The ASR Hip Resurfacing Platform was not approved for use or sold in the US.

DePuy AST Systems Recall

Citing new data they received from the National Joint Registry of England and Wales, DePuy voluntarily recalled both the ASR XL Acetabular and ASR Hip Resurfacing Systems on August 26, 2010. The data showed that the need for a second replacement operation, a revision surgery, within five years of the original surgery was higher than expected. The 2010 National Joint Registry data showed that of the patients with DePuy ASR hip devices, 13% with complete hip replacements and 12% with resurfacing devices needed corrective surgeries within an average of 5 years.

It is estimated that 93,000 patients worldwide have received one or the other of the defective hip devices. In 2009, DePuy discontinued manufacture of both hip implants, allegedly due to declining demand and a desire to develop the next generation of hip replacement and resurfacing devices. A suit against the company filed by a California construction worker claims that DePuy knew for years that the ASR hip implants were defective. By the end of 2008, there were approximately 300 reports of hip implant failures in surgeries using the ASR hip devices.

Human Hip Joint ASR

ASR XL Acetabular is composed of three parts:

  • A one–piece acetabular cup, a metal liner, replaces the acetabulum
  • A femoral stem which is inserted inside the femur
  • A femoral head (or ball) connects to the stem and fits inside the acetabulum

Due to its design, metal surfaces within the device grind against each other causing toxic metal particles to be released into the body. This causes the body to reject the implant, not allowing it to grow properly into the bone.

The need for revision surgery is highest in those whose implant head size is below 50mm in diameter. It also appears to be more common in women patients who have received the hip implant than in men. If you have received either of the ASR implants, DePuy is recommending that you visit your surgeon and undergo yearly monitoring to make sure that it is functioning properly. Any unexplained hip pain or if it feels like the hip implant is loosening may indicate that the hip replacement is failing and should be reported to your surgeon immediately.

“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.”

FDA Warnings on Two Other DePuy Products

The recall of the ASR XL Acetabular and ASR Hip Resurfacing Systems comes on the heels of an FDA warning received by DePuy regarding selling other hip replacement systems for unapproved uses. The FDA warning claimed that DePuy violated the Federal Food, Drug, and Cosmetic Act by marketing their TruMatch™ Personalized Solutions System and Corail®Hip System without first receiving the required marketing clearance and/or approval. The FDA’s warning letter was dated August 19, 2010—seven days later the company issued its recall of both ASR hip implants.

Your Legal Options

Our defective medical device attorneys are currently evaluating cases concerning the ASR XL Acetabular System used in hip surgeries performed in the United States. If you or a loved one has received the ASR XL Acetabular hip implant, please contact us through this simple form or our toll–free number, 866–809–5240.