Zimmer Hip Replacement Claim Center

Statement by Zimmer Holdings, Inc.
New York Times Article
July 29, 2008

An article in the July 29, 2008 edition of The New York Times on the need for joint registries to effectively track post-market patient outcomes does not provide sufficient context and data about the life-changing and well documented benefits achieved by millions of hip replacement surgery patients.  The article also does not provide a fully balanced review of the real-world challenges associated with applying medical device registry data to follow post-market patient outcomes, nor the comprehensive process Zimmer undertook to investigate performance of the Durom® Acetabular Component (Durom Cup) and take rapid action to address surgical training needs in the United States.  The Company therefore provides additional information on these important subjects, including its commitment to post-marketing surveillance and vigilance.

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Today in an article titled ‘Zimmer Durom Cup Problems Highlight Need for Joint Registry’ the New Yorks time highlighted the recent controversy surround the Zimmer hip implant recall and the need for a national database, called a joint registry.

“Hundreds of patients receiving Zimmer Durom Cup hip implants in the U.S. have been experiencing serious problems since the device was introduced in 2006.  But it wasn’t until this past April, when a prominent surgeon went public with his concerns about the Durom Cup, that physicians learned of the widespread nature of the complaints.  Now, patient advocates are calling for the creation of a national database, called a joint registry, that tracks how patients with artificial hips and knees are doing.  Such a system, they argue, would quickly alert doctors and federal regulators to devices that have a high failure rate, possibly sparing tens of thousands of patients from severe, painful injuries.”

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Since we last wrote to you in May 2008 regarding the Durom® Acetabular Component (“Durom Cup”), Zimmer has completed an extensive investigation of clinical experience with this product and its conformance to specifications. We are able at this time to share with you key conclusions and actions with respect to the Durom Cup in the United States.

• The results of our in-depth investigation have led us to conclude that additional surgical technique instructions and training are necessary in the United States, and we strongly recommend that U.S. surgeons stop implanting the Durom Cup until receiving such training.
• Zimmer will suspend marketing and distribution of the Durom Cup in the U.S., while we update product labeling to provide more detailed surgical technique instructions and implement a surgical training program for U.S. surgeons.
• The Durom Cup will continue to be marketed and distributed without interruption outside the U.S.

Our investigation included clinical and radiographic data review from users of the Durom Acetabular system, including those who have been pleased with their results, as well as users who are experiencing a higher than desired rate of revision.

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Zimmer Holdings, Inc (NYSE and SWX: ZMH) is temporarily suspending marketing and distribution of the Durom® Acetabular Component (Durom Cup) in the United States, while the Company updates labeling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S. The Durom Cup will continue to be marketed without interruption outside the U.S.

Zimmer is taking this voluntary action to address its concerns regarding reports of cup loosenings and revisions of the acetabular component used in total hip replacement procedures, in some patients who have been implanted with the Durom Cup in the U.S.

While many U.S. surgeons have had success implanting the Durom Cup, a subset have experienced elevated revision rates since the product was launched in the U.S. in 2006. These results contrast with product experience in Europe, where post-marketing data continue to show excellent clinical outcomes since the product launched in 2003. Following a comprehensive review of clinical experience and product conformance to specifications in the U.S. and Europe, Zimmer has found no evidence of a defect in the materials, manufacture, or design of the implant. The Company has identified that surgeons who regularly achieve the desired outcome with the Durom Cup consistently execute crucial technique steps and place the cup in a specific manner. Following its review, Zimmer has determined that revised surgical technique instructions and a surgical training program are required to more consistently achieve desired clinical results in the U.S. The Company has shared its review and conclusions with the U.S. Food and Drug Administration (FDA) and will continue to update the Agency.

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