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DePuy Orthopedics Announces ASR Hip Implant Systems Recall

On August 26, 2010, DePuy Orthopedics, Inc., a division of Johnson & Johnson, announced a worldwide recall of two hip implant systems – the DePuy 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 that involves placing a metal cap on the ball of the femur. DePuy has estimated that 93,000 total devices have been implanted worldwide.

As the New York Times reported in March 2010, for more than two years, the Food and Drug Administration (“FDA”) has been 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 DePuy ASR™ XL Acetabular System, data now reveals that 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 have been under increasing scrutiny reportedly due to their metal-on-metal bearings which can generate debris from wear, in turn causing tissue damage and inflammation in some patients. In the fall of 2009, DePuy began “phasing out” the use of the ASR implant systems.

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

According to an Associated Press blog released today, this is the 11th recall issued by Johnson & Johnson (or a J&J subsidiary) since last September. For the official recall issued on DePuy’s website, click here.

Kershaw, Cook & Talley are 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 lawyers have represented 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 have represented.

If you or a loved one has had hip replacement surgery, you should contact your doctor to find out if the ASR Hip System was used. It is important that you do not sign anything from Johnson & Johnson or DePuy before speaking with a medical attorney!

Problematic symptoms 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 (ie. cobalt or chromium) in the bloodstream

Prolonged symptoms may indicate a problem such as:

  • Loosening or detachment of the implant
  • Fracture of the bone around the implant
  • Dislocation of the two parts of the implant

What should you do if you have undergone hip replacement surgery?

If you believe that you or a loved one may be affected by this recall, first call your doctor to find out if the DePuy ASR Acetabular XL Replacement or Resurfacing devices were used.  If your doctor confirms that you do have the recalled device implanted in your body, contact us for a free and confidential case evaluation at 888-817-2527, or by filling out the contact form found throughout our site.

For more information on cobalt & chromium toxicity, visit our new website that features in-depth interviews with renown metal toxicology expert: www.cobalt-chromium-toxicity.com

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DISCLAIMER:

By sending this email information to Kershaw, Cook & Talley, an attorney-client relationship is not created between you and Kershaw, Cook & Talley, or any other party. An attorney-client relationship does not exist until a formal “Attorney Retainer/Fee Agreement” has been signed by all parties.

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