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Cabraser is one of the nation's leading personal injury law firms
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Safety News Article Excerpt |
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| July 24, 2008 |
Ortho Supersite, "Zimmer temporarily suspends marketing, distribution of Durom acetabular hip replacement component" |
Zimmer Holdings Inc. announced in a press release that it is temporarily suspending marketing and sales of the Durom acetabular component – also known as the Durom Cup – in the United States. The company also lowered its earnings outlook as a result of the suspension, and its shares fell sharply the day after the announcement was made. The company will update labeling for the Durom Cup to provide more detailed surgical technique instructions to surgeons, and the company will implement a surgical training program in the United States.
While many U.S. surgeons have had success implanting the cup, a subset of patients have experienced "elevated revision rates" since the product was launched in the United States in 2006, according to the press release. However, this contrasts with "excellent" clinical outcomes reported by surgeons in Europe, who have used a slightly different version of the product since 2003, Zimmer officials said. The product is also used more frequently in hip resurfacing procedures in Europe.
The Durom Cup will continue to be marketed without interruption outside the United States. Zimmer officials said they are taking this voluntary action to "address [company] 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 United States."
Learn more about Zimmer Durom hip implant injuries and your legal rights. |
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