Cobalt-Chromium Toxicity Resource Center

DePuy ASR™ Acetabular Hip Replacement Recall

DePuy ASR™ Acetabular Hip Replacement Recall

On August 26, 2010, DePuy Orthopedics, Inc., a division of Johnson & Johnson, announced a worldwide recall of two hip implant systems – the ASR™ XL Acetabular System and the ASR™ Hip Resurfacing System. The ASR™ XL Acetabular System is a hip socket used in traditional hip replacement, while the ASR™ Hip Resurfacing System is a partial hip replacement system involving placement of a metal cap on the ball of the femur. DePuy estimated 93,000 total devices were implanted worldwide.

As the New York Times reported in March 2010,the Food and Drug Administration (FDA) is receiving complaints that the devices subject of the announced recall have a high failure rate. In fact, since the beginning of 2008, the FDA reportedly received over 400 complaints involving United States patients. The FDA recently sent DePuy a warning letter regarding their knee and hip replacement devices, stating that the company has illegally marketed unapproved medical devices.

Regarding the ASR™ XL Acetabular System, data now reveals the five year revision rate is approximately 13 percent, while the five year revision rate for the ASR™ Hip Resurfacing System is approximately 12 percent. These revision rates are across the entire size range of the devices. The risk for revision is reportedly the highest with ASR™ head sizes below 50 mm in diameter and among female patients. The ASR™  systems are under increasing scrutiny reportedly due to their metal-on-metal (MOM) bearings which generate debris from wear, in turn causing tissue damage and inflammation in some patients. In Fall of 2009, DePuy began “phasing out” the use of the ASR™ implant systems.

DePuy recommended patients implanted with the affected devices visit their doctors for an evaluation and monitoring. DePuy also said it would pay “reasonable and customary” medical costs associated with its recall, including further surgery. However, this may not be nearly enough to cover the significant expenses, pain and continued suffering experienced by patients. Patients suffered, and will continue to suffer severe injury, disability, lost wages, physical and mental pain and suffering, and possibly death as a result of the defective implants – not to mention the distress felt by the patients’ spouses and families.

According to an Associated Press blog, this is the 11th recall issued by Johnson & Johnson (or a J&J subsidiary).

Symptoms of Hip Replacement Failure Include:

  • hip, groin, leg or lower back pain and/or swelling
  • problems walking
  • extreme fatigue or decline in physical ability
  • audible clicking or crunching sounds coming from the hip area
  • inflammation and infection
  • a sensation of hip dislocation
  • elevated metal levels (i.e. cobalt or chromium) in the bloodstream

Prolonged Hip Replacement Problems that may Require Revision Surgery Include:

  • loosening or detachment of the implant
  • fracture of the bone around the implant
  • dislocation of the two parts of the implant
  • excessively high metal levels (i.e. cobalt or chromium) in the bloodstream

Contact an Experienced Medical Device Recall Attorney

If you had hip replacement surgery, contact your doctor to find out if the ASR™ Hip System was used.  Do NOT sign anything from Johnson & Johnson or DePuy before speaking with a medical device recall attorney.

Kershaw, Cook & Talley is dedicated to protecting the legal rights of patients affected by the hip replacement device recall, and we are prepared to devote our substantial resources through trial. Our expert medical lawyers represent thousands of victims of defective medical devices, dangerous drugs and consumer products in cases throughout the country, generating hundreds of millions of dollars in recoveries for our clients and the classes we represent.

Please contact us for a free and confidential case evaluation at 888-817-2527, or fill out the contact form found throughout our site.

Getting the help you deserve

Do you have an advocate looking out for your best interest? At Kershaw, Cook & Talley, we represent hundreds of hip replacement patients who, for decades, continue to rely on our knowledge and expertise in fighting and winning cases in the mass tort and medical device arenas. All it takes is 3 simple steps! Start by sharing your story with us through our free evaluation form on this page or we invite you to give us a call, toll free, at 888-817-2527 for a confidential case review.

At Kershaw, Cook & Talley, we look forward to serving you and your family.

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