On July 22, 2008, Zimmer Holdings, Inc. announced it will suspend marketing and sales of its Durom® Acetabular Component (Durom Cup) in the United States. The suspension is due to complaints from doctors that the artificial hip component is failing at a high rate.

The Durom cup is used in total hip replacement procedures, which are performed in more than 442,000 patients in the United States each year. The cup was developed to relieve pain and improve joint function in patients with severe hip degeneration due to arthritis or trauma.

In the months leading up to the suspension, some doctors complained the device was failing in their patients, who then underwent replacement surgery. Zimmer received complaints about loosenings of the Durom cup, prompting the company to launch an investigation to determine whether the product was defective.

The investigation found that experienced surgeons reported difficulty implanting the Durom cup. Zimmer asserts the product is not defective. Zimmer also cited evidence that the product was doing well in Europe, but the version of the Durom cup used in Europe differs from the version used in the United States. Surgeons in other countries also perform a different, relatively new kind of hip surgery.

Zimmer said sales and implantations of the Durom cup are to be halted until it can update the products label to provide more detailed surgical technique instructions and implement a surgical training program.

The Durom cup was first sold in the United States in 2006, and has been implanted in more than 12,000 patients. Zimmer expects the number of early replacement surgeries needed to be minimal, but hundreds of patients may need replacement surgeries in the next several years.

Sources: Barry Meier, “Complaints undermine hip device,” The New York Times, July 24, 2008; “Background on Durom® Cup Status,” Zimmer Holdings, Inc. announcement, July 22, 2008.