Zimmer temporarily suspends marketing, distribution of Durom acetabular 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.

Zimmer 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.

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," according to the press release.

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 news 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.

In the press release, company officials said 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 is has been implanted in more than 12,000 U.S. patients since it was launched in the United States 2 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.