Durom acetabular
component
Zimmer Holdings Inc. is temporarily suspending marketing and sales of the Durom acetabular component - also known as the Durom Cup - in the United States. The company lowered its earnings outlook as a result of the suspension, and its shares fell sharply after the announcement was made.
The company will update labeling for the Durom Cup to provide more detailed surgical technique instructions, and will implement a surgical training program in the United States. 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."
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 since 2003, Zimmer officials said. The product is also used more frequently in hip resurfacing procedures in Europe.
Company officials stated they found no evidence of a defect in the materials, manufacture or design of the implant. However, a number of surgeons - including some with extensive total hip replacement experience - found the component challenging to implant.
The Durom cup has been implanted in more than 12,000 U.S. patients since it was launched in the United States two years ago.
In a July 24 New York Times article, Zimmer officials said the sales suspension would cut $20 million to $30 million from the company's sales estimates. Zimmer said it expected that earnings for the year would be $4.05 to $4.10 a share, down from its earlier forecast of $4.20 to $4.25 a share.
Read about a Zimmer recall of a knee device at:
https://www.dotmed.com/news/story/6480/
