DePuy ASR Recall Issued After Warning About Hip Replacement Failures

The market withdrawal of the DePuy ASR hip replacement system earlier this year, combined with a warning to physicians about the high failure rate associated with the device, are now being called a DePuy ASR recall by the FDA. 

The FDA indicated on July 17 that the actions of DePuy Orthopaedics, a subsidiary of Johnson and Johnson, in regards to its ASR hip implant were classified as a Class 2 medical implant recall. Specifically, the company’s notification to clinicians of new revision rate information regarding the use of the devices was cited as a reason for the DePuy ASR hip recall.  

The manufacturer initially indicated that their decision to remove the device from the market was not issued due to any safety problems with DePuy ASR hip cups, rather because of low sales numbers. However, on March 6, DePuy sent a letter to doctors indicating that the ASR hip implant has been linked to a high failure rate. Many patients who received DePuy ASR hip replacements have experienced hip failures soon after the device was implanted, leading to additional hip surgeries.

The DePuy hip recall involves 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm.

The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.

Between 2007 and 2009, reports of problems with the DePuy ASR hip began to spike, with nearly 100 recipients reporting problems in 2007, more than 200 reporting problems in 2008, and more than 300 reporting problems in 2009. Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopaedics and found that 3.4 percent suffered from adverse reactions to metal debris. Surgeons are warning that one to three percent of all metal on metal hip implant recipients may experience hip implant problems, and possibly need to have the devices replaced, due to metallic debris.

In recent months, a number of DePuy hip lawsuits over faulty ASR Cup implants have been filed. It is expected that the number of cases will continue to grow as Depuy ASR recall lawyers continue to investigate and review potential cases for individuals who have experienced problems and complications after hip replacement surgery involving the device.

Failure and Defect of the Zimmer Durom Hip Replacement System Cup

On July 24th, 2008, Zimmer Inc. had a recall on their prosthetic hip implant the Durom Cup. The Durom Cup has been implanted in over 12,000 patients since it was first sold in the United States in 2006.

Indeed, on April 22, 2008, Dr. Larry Dorr, a world renowned orthopedic surgeon and Director of the Dorr Institute for Arthritis Research and Education, wrote the following letter to his colleagues at the American Association of Hip and Knee Surgeons warning of the failures and defects associated with Zimmer’s Durom hip cup:

This failure rate has occurred within the first two years. In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions.

If you or someone you know has had a Durom hip cup surgically implanted and believe it has failed, was defective, needs to be removed, or has already been revised, you should have your potential defective hip case reviewed. If you do not know if your hip implant is a Durom hip manufactured by Zimmer, Inc., call your surgeon and get a copy of your hospital medical chart.

Please retain your orthopedic surgeon's office chart, the operative reports for the original joint replacement surgery and the revision surgery, the device record for the original surgery from the hospital chart and the Durom hip resurfacing cup.

Consult A Doctor On Medical Issue
The Steinberg law firm does not intend, by this web site or otherwise, to dissuade anyone from taking medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. Patients should talk to their physicians to decide whether they are at risk with their hip implant.

Consult A Lawyer on Legal Issues
If you or a loved one have suffered an injury due to a defective hip implant from either Zimmer Inc. or Stryker Corporation, call or e-mail for a free consultation.

Please e-mail Andrew E. Steinberg* at:  andrewsteinberg@lawyer.com for a free, confidential consultation, or call us at 888-529-4688.

Our description of your legal rights is not intended to imply that any product is defective. That can only be determined through a case-specific investigation.

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