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Zimmer Suspends Sales of Hip Implant Component Following Complaints

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Zimmer Holdings is suspending sales of  the Durom cup hip implant component that some say is failing at high rates. Zimmer said it expected general need for early replacement of the device in patients to be low; however, Zimmer data and interviews with doctors suggest that hundreds of patients might need such procedures going forward.

As a result of halting sales, Zimmer said that it was also suspending United States premarketing trials of its system for resurfacing, the surgical process that is used in Europe with the Durom cup. That decision will put Zimmer further behind competitors that already have such products on the American market.

The Durom cup has been implanted in over 12,000 patients since it was first sold in the United States in 2006. Problems with the Durom cup became known in April when a Los Angeles surgeon, Dr. Lawrence Dorr, publicly warned other orthopedists about cup failures he was hearing about from his patients. At that time, Zimmer said it would initiate an investigation but that it saw no reason to take other action, such as halting sales. Zimmer cited European data that indicated that the Durom cup was doing well there; however, the version of the Durom cup used outside the US is a bit different from the one used in the US. Additionally, while US doctors use the Durom cup in traditional hip replacement surgeries, surgeons in other countries use the device in a relatively new kind of hip surgery known as resurfacing, which involves different surgical techniques.

Zimmer, which announced the sales suspension late Tuesday, said its investigation found that using the cup required a higher degree of precision. Dr. Dorr, who said he had stopped using the device last year, said he did not plan to start reusing it. “It is a bad design,” he said. Mr. Nudell, the analyst, said other doctors were happy with the cup, but he expected Zimmer might see a 50 percent drop in the product’s use when sales resumed.

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