Zimmer Holdings, the nation’s top artificial joint component manufacturer recently announced that it is re-releasing its Durom Acetabular Cup, a hip replacement part, to doctors again, but only to those who complete special training on its use. This announcement comes after sales of the Durom Cup were suspended by Zimmer in July 2008 after reports that the component was defective and failed to bond in many patients, thereby causing patients to undergo painful revision surgeries. Approximately 12,000 patients had the Zimmer Durom Cup system implanted between 2006 and 2008, and accordingly to Zimmer’s own research estimates, almost 8% of the people that received the initial hip replacement required a revision surgery withing a two year period. The high failure rate is caused by the Durom Cup’s inability to bond with the host bone, causing the implanted part to loosen and move. Some hip replacement devices have been associated with metallosis.
The Zimmer Durom Cup was first introduced in the United States in 2006 as a more advanced form of an artificial hip. The hip resurfacing system consists of a single piece of material and is designed to avoid problems associated with traditional hip replacement components, such as instability and limited range of motion. However, in April 2008, concerns emerged about a high number of Zimmer hip replacement failures involving the Durom Cup, where the component loosened and required revision surgery.
After suspending sales of the product July 2008, Zimmer has now made revisions to the warning label and requires additional training and instructions for surgeons about the special surgical techniques needed to reduce the risk of problems. However, lawsuits have been filed throughout the country alleging that Zimmer did know or should have known of the risks and should have been warning and educating doctors about the potential bonding problems.
In January 2009, Zimmer Holdings, Inc. indicated during a fourth-quarter earnings report that at least $69 million has already been set aside in reserves to cover payments for potential Zimmer Durom hip replacement lawsuit verdicts and settlements that they may need to pay to patients.
At PGMBM, protecting our clients is our primary goal. We recognize that drug companies are under an obligation to warn about the known risks of their products. When they fail to do so, they may be held responsible for the injuries or deaths that are the consequence of their inaction.
If you or a loved one has suffered complications as a result of a Zimmer Durom Cup, you should immediately contact the attorneys at PGMBM, where Protecting Consumers Is Our Primary Goal.
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PGMBM (a trading name of PGMBM Law Ltd)
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