DePuy Hip Replacement Recall

DePuy Orthopaedics, Inc. is recalling all of its ASR XL Acetabular Hip Systems and ASR Hip Resurfacing Systems after years of complaints that the product is defective. These metal on metal prosthetic systems have been in use since 2003.

Patients who received these implants have reported:

  • Pain
  • Popping
  • Grinding
  • Metal sensitivity
  • Loosening of the prosthesis
  • Infection
  • Dislocation
  • Bone fracture
  • High metal ions levels in their bloodstreams

Many patients must undergo painful revision surgery to have the implant removed and replaced.

Approximately 13% of patients with the ASR XL Acetabular System must undergo surgery again within five years, according to DePuy. That rate is approximately 12% for ASR Hip Resurfacing System patients, DePuy said. These revision rates are much higher than other hip implant systems on the market. Generally, hip implant prosthetics are designed to last approximately 15-20 years.

Numerous DePuy ASR patients have complained about these now-recalled products to the Food and Drug Administration since 2008. Nonetheless, it was not until March 2010 that DePuy first addressed these complaints. At that time, DePuy issued a Field Safety Notice to physicians regarding the surgical revision rates of its ASR systems. DePuy told doctors in that urgent notice that surgical revision rates of its ASR metal on metal products were higher than expected. In April 2010, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a Medical Device Alert warning of the dangers of all metal on metal hip implants.

Finally, on August 24, 2010, DePuy issued a recall of the hip implants. Approximately 93,000 devices have been implanted worldwide, according to DePuy. The company does not keep track of the identities of the patients who receive their implants. DePuy Orthopaedics, Inc. is a Johnson & Johnson company.

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