Zimmer Holdings, Inc. disclosed last week that they have set aside $47.5 million to pay claims related to their Durum hip replacement part, which was temporarily pulled from the market in July 2008 after a number of patients experienced loosening of their hip implant and the need for hip replacement revisions.
The Zimmer Durom Cup was approved in 2006 for use in the United States, and over 12,000 people have had the device implanted by doctors who may not have been properly informed by Zimmer about the special surgical techniques required to reduce the risk of problems. As a result, a surprising number of hip patients have had their hip replacement fail.
In July 2008, Zimmer suspended sales of the Durom Acetabular Component, or Durom Cup, after confirming that some clinics using the hip implant were experiencing failure rates as high as 5.7%.
The Zimmer Durom Cup was reintroduced in August after revisions were made to the product labeling and training programs were developed to instruct surgeons about the techniques necessary to reduce the risk of the hip implant loosening after surgery.
Physicians are required to complete the new internet-based training program before the Zimmer Durom hip implant is made available to them. So far, Zimmer indicates that only half of the hip replacement surgeons who were using the Durom Cup have elected to go though the additional training.
According to a statement released Thursday, the medical device manufacturer has adjusted their third quarter earnings statement to set aside $47.5 million for potential Zimmer Durom Cup lawsuits.
Although hundreds of potential cases are being reviewed by product liability lawyers, at this time Zimmer is only setting aside money to cover “revisions associated with surgeries that predate the company’s voluntary suspension and which also occur within two years of the original surgery date.”
Zimmer has not disclosed how many reports they have received of hip replacement failures among patients receiving their hip implant. Several Durom implant lawsuits have already been filed against Zimmer and the company’s liability will likely exceed the money they are setting aside at this time.