Zimmer Suspends Distribution of Device, Lowers Sales Forecast
After issuing an urgent device correction letter encouraging surgeons to stop implanting its Durom Acetabular Component until they have received additional training, Zimmer Holdings lowered its sales expectations for the year.
The temporary suspension applies only to Durom Cups distributed in the U.S., where they are used in total hip replacement procedures.
Zimmer halted distribution after examining its manufacturing process and data from more than 3,100 device users in the U.S. and abroad. The investigation revealed incidents of the cups loosening and a revision surgery rate of 5.7 percent when the cup was not placed in a specific manner or “crucial technique steps” were not taken.
The company said there was no evidence of any material, design or manufacture defects. The investigation concluded that surgeons who do not use specific techniques have a lower success rate.
Zimmer will implement a training program for surgeons in the U.S., Cheryl Blanchard, the company’s chief scientific officer, says in the letter to surgeons. The company also is revising the product labeling, developing patient management guidelines, providing a guide to surgeons on talking to patients and providing direct support to patients.
The device is a cobalt-chromium alloy cup designed to be used with Zimmer’s Metasul Metal-on-Metal Tribological Solution LDH for total hip replacement. It has a titanium plasma-sprayed coating. It was launched in Europe five years ago for hip resurfacing — an alternative to hip replacement — but the FDA has not approved it for that use. It also is available in Canada, Australia, India, Korea and Argentina for hip resurfacing.
The letter to surgeons is available at www.zimmer.com/web/enUS/pdf/DUROM_SURGEON_LETTER_07-22-08_FINAL.pdf.