Zimmer suspends marketing of hip device

Zimmer Holdings has suspended the marketing and distribution of the Durom Cup, a hip socket component of a replacement hip, in the U.S. on a voluntary basis.

By Kristen J. Light

Zimmer Holdings has suspended the marketing and distribution of the Durom Cup, a hip socket component of a replacement hip, in the U.S. on a voluntary basis. The company plans to update the product’s labeling to provide more detailed surgical technique instructions and to implement its surgical training program in the U.S. The Durom Cup, however, will continue to be marketed without interruption outside the U.S.

Zimmer, based in Warsaw, IN, made its decision to suspend the hip component due to pressure from physicians and medical associations. A July 24 article in The New York Times reported that some doctors had complained that Zimmer’s hip socket was failing their patients at a high rate.

The Durom Cup has been implanted in more than 12,000 patients since it was first sold in the U.S. in 2006, according to the article. The issue first surfaced in April when a surgeon in Los Angeles public­­­ly warned other orthopedists about cup failures experienced by some of his patients.  Zimmer responded to the allegation by saying it would begin an investigation, but it saw no reason to halt device sales, the Times reported.

At the same time the company was receiving complaints in the U.S., it cited data showing that the Durom Cup was doing well in Europe. The U.S. version of the device, however, is slightly different from the one used in other countries. Foreign surgeons use it for hip resurfacing surgery, which involves a different surgical technique than the traditional hip replacement methods commonly used in the U.S.

Zimmer said that its investigation had determined that while even some experienced surgeons had found the device difficult to implant, the product was not defective, according to the Times article. However, the company announced in late July that it will suspend sales of the artificial hip component and will not resume sales until specialized training for doctors has begun.

Zimmer lowered its earning outlook as a result of the suspension, and its shares fell sharply, according to the Times article. The company reported second-quarter net sales of $1.08 billion, an increase of 11% reported and 5% constant currency over the second quarter of 2007. Diluted earnings per share for the quarter ended June 30 were $0.99 reported and $1.03 adjusted, an increase of 5% adjusted over the prior period.

The company also has resumed Zimmer Institute training activities, which will support the upcoming launches of several key products. These include the Zimmer Nex­Gen LPS-Flex Mobile Knee, the Gen­der Solutions Natural-Knee Flex, and the Gender Solutions Patello-Femoral Joint System devices for knees. The company’s hip products include the VerSys M/L Taper Hip with Kinectiv Technology and the Fitmore Hip stem. Zimmer anticipates FDA clearance to market the Epoch Gender Solutions Hip during the second half of the year.