DePuy Hip Replacement, FDA Alerts

The U.S. Food and Drug Administration (FDA) has published numerous alerts, cautioning healthcare professionals and patients about the failure of two of DePuy's recalled hip implant devices, the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System.

The alerts include information for physicians who provide treatment to patients with a metal-on-metal hip implant system. This alert warned physicians about the possibility of "device wear in metal-on-metal hip systems," including problems this system generated such as:

  • Cardiomyopathy (disease of the heart muscle)
  • Thyroid dysfunction
  • Neurological changes that include sensory, auditory and visual impairments

The FDA alert suggested that a patient with these symptoms would more likely follow up with a general practitioner or medical specialist instead of his or her orthopedic surgeon. The FDA wanted to be sure these physicians were aware of possible implant side effects so that these doctors would refer these patients to their orthopedic surgeons.

Alerts Issued by the FDA

  • An alert about the "concerns about metal-on-metal hip implant systems," warning of the risks of metal-on-metal implants that include localized problems of the metal shedding particles and inflaming nearby bone and tissue, but also causing symptoms elsewhere in the body including in the heart, the thyroid and then nervous system.
  • A notice explaining the role of the FDA in regard to its activities to further asses the safety and effectiveness of metal-on-metal hip implants.
  • An announcement on DePuy's recall of two of its hip implant systems.
  • A patient information sheet for those with metal-on-metal hip implants.
  • A request that patients, physicians and manufacturers report adverse events associated with metal-on-metal devices to help the FDA learn more about the occurrence of these problems and assess their public health impact.
  • Two notices giving general description of metal-on-metal hip implants and their consequences plus the possibilities of problems associated with surgery.

DePuy Hip Implant Recall

On Aug. 26, 2010, DePuy issued a voluntary recall of the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System. The recalls were a result of hundreds of failures of the implant systems, their effects on the body, the need for revision surgery (another operation), and the expectation of many more failures to come. The number of lawsuits, which have now been put into Multidistrict Litigation, is at least 600.

Learn more by contacting our DePuy hip implant recall attorneys for a free case evaluation.

DePuy Hip Replacement Recall Information intends to provide patients with up-to-date information about the recent DePuy hip implant recalls. For more information, please select from the following:

Depuy Hip Implant News

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Depuy Hip Recall Lawyers