Zimmer Durom Hip Replacement Part Defect Leads to Suspension

On July 24, 2008, Zimmer Holdings announced the suspension of sales of an artificial hip implant component due to a high failure rate. Zimmer Holdings is the nation’s largest producer of orthopedic devices. The medical device suspended is the Zimmer Durom hip replacement part, also known as the Zimmer Durom Acetabular Cup, was first sold in the U.S. in 2006 and has been implanted in approximately 12,000 patients.

This suspension is due to high implant failure rates, caused by the cup’s inability to bond with the host bone, resulting in the replacement part to migrate. Reports of these problem began in April 2008, yet Zimmer allowed thousands of people to receive artificial hip implants without adequately disclosing the risks and necessary surgical techniques.

Other reports suggest that Zimmer did not suspend the Durom hip implant for being defective, but rather suspending its sale to provide doctors specialized training for the surgery. The company also states that they expect sales to resume once specialized training for doctors had begun. However, not all doctors agree with this statement, instead reporting wide belief that the fixation surface is not good on the cups, and the circular cutting surface on the periphery of the cup actually prevents the cup from fully seating. Many Doctors have stopped using the cup for hip replacement implants.

The FDA has been notified of this defect, and Zimmer’s own research data estimates that some doctors experienced hip failure rates as high as 5.7% with the Durom Cup. Zimmer continues to face lawsuits from people who have had the defective hip replacement implanted, and suffered severe side effects.

Source: TransWorldNews

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