Depuy Hip Implant Recall

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On August 26, 2010, DePuy announced a voluntary recall of all ASR hip implant systems sold since 2003.[1] These devices had already been withdrawn from the Australian market in December of 2009.[2] Research released by the National Joint Registry (NJR) determined that the five-year failure rate of for the ASR XL Acetabular and ASR Hip Resurfacing systems was approximately 13 percent, or 1 in 8 patients.

The recall includes two hip implant models. One of these was rejected by the FDA, but the company still sold it in Europe and other regions until it was ultimately recalled.[3]

DePuy, a division of orthopaedic and neuroscience companies within the Johnson & Johnson Medical Devices & Diagnostics group, develops and markets joint, spine and bone reconstruction products under the Codman, DePuy Mitek, DePuy Orthopaedics and DePuy Spine brands.[4]



DePuy Orthopaedics, Inc.
Manufacturer DePuy, a division of Johnson & Johnson[3]
Telephone 888-627-2677<ref=recall2>http://asrrecall.depuy.com/asr-hip-replacement-recall</ref>
Uses Hip replacement[3]
Date of recall August 26, 2010[1]
Disclaimer The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
 

Contents

DePuy Recall 2010

Approximately 93,000 DePuy prosthetic hip devices have been implanted worldwide. The FDA had been receiving complaints that these devices were failing early for almost two years prior to the recall. Hip implant failure requires addition expensive and painful operations to implant replacements.[5] DePuy fast-tracked the approval process of the implant devices through the FDA, circumventing the formal process that would have involved rigorous clinical tests. This abbreviated FDA approval process is known as the 510(k) process, and is permitted if the manufacturer states that its product is "substantially equivalent" to other devices that have already been approved by the agency.[6]

DePuy claims that the majority of hip replacement surgeries with their devices have been successful. Patients who have had hip replacements with the recalled DuPuy products have been advised to schedule an appointment with their surgeons for evaluation and annual monitoring. DePuy has agreed to pay reasonable and customary medical costs associated with the recalled products, including the cost of surgical hip replacement. Pain and suffering is also being compensated in some instances.

According to the Depuy Hip Replacement Guide, they are committed to providing ASR patients with the support and information necessary for their recall-related medical care.[7] DePuy is working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. DePuy's sales in 2009 exceeded $5.4 billion, according to a Johnson & Johnson earnings report.[5]

Patients who had hip surgery after July 2003 should contact their orthopaedic surgeon or the hospital of record to determine if they received an ASR Hip. Patients with an ASR Hip may contact the DePuy ASR Help Line at 888-627-2677 between the hours of 8 a.m. to 9 p.m. EST, Monday through Saturday, to schedule additional testing and treatment.

DePuy Lawsuits

The first United States lawsuit against DePuy Orthopaedics was filed on June 15, 2010. The lawsuit claims that the DePuy ASR was defectively designed, and that DePuy was aware of issues with the implant but did not contact patients or their surgeons about the potential risks. The United States Judicial Panel on MultiDistrict Litigation ruled on December 7, 2010 that all cases filed across the country regarding the Depuy prosthetic devices be "transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable David A. Katz for coordinated or consolidated pretrial proceedings."[8]

Initial FDA Rejection

One of the models of recalled DePuy implants had initially been rejected by the FDA, and was not considered safe enough to use in the United States. However, Johnson and Johnson still decided to sell the implant, shipping it overseas where FDA approval was not needed. Like the other recalled products, the implant contains a faulty metallic hip socket cup.[3]


FDA Fails on DePuy Hip Replacement

Mike Papantonio discusses the DePuy medical device recall with attorney and Consumer Advocate Ben Gordon.

Also see: Johnson and Johnson Recall, Motrin Recall, Benadryl Recall, Tylenol Recall, Lipitor Recall, Miralax Recall, Mylotarg Recall, Birth Control Recall, Enfamil Recall, NIH

References

  1. ↑ 1.0 1.1 http://www.arthritistoday.org/news/asr-depuy-hip-replacement-recall078.php
  2. ↑ http://mydepuyrecall.com/depuy-hip-implant-recall-history.htm
  3. ↑ 3.0 3.1 3.2 3.3 http://www.nytimes.com/2012/02/15/business/hip-implant-the-fda-rejected-was-marketed-abroad.html
  4. ↑ http://www.hipreplacement.com/DePuy/about_depuy/index.html
  5. ↑ 5.0 5.1 http://www.nytimes.com/2010/08/27/business/27hip.html
  6. ↑ http://mydepuyrecall.com/docs/depuy-asr-xl-hip-implant-fda-510k.pdf
  7. ↑ http://asrrecall.depuy.com/asr-hip-replacement-recall
  8. ↑ http://www.hiprecalldepuy.com/US%20Judicial%20Panel%20on%20Multidistrict%20Litigation%2012072010.pdf
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