Friday, February 20, 2009

Reasons for a Zimmer Durom Cup Recall

By Maxwell Schmickman

Everyone involved in Zimmer Durom Cup hip implant surgeries in the United States, from company stockholders to implant patients to physicians are still unhappy with the way Zimmer Holdings, Inc. handled its American sales. Although many of these people were demanding a product recall after the device failed in a large number of patients, Zimmer has been clinging to the previous reputation established by successful surgeries in Europe instead of being quick to act on the problems that began to crop up in the U.S.

It was January, 2008 when Zimmer first realized that there were problems with the implants. However, they didn't announce the information to the public and suspend the sales of the device until July. Because the implants had worked so successfully in Europe, they found it hard to believe that they could be the cause of the problems in the U.S. Rather than take them off the market while they investigated possible causes, they chose to keep them there until they had more information about what was causing patients to need revisions so quickly.

Using information taken from 3,100 implant surgeries, Zimmer put together a database of material so that their researchers could study the problem in detail. After a great deal of study, they determined that there was nothing wrong with the implant technology. What they found was that American doctors hadn't received adequate training prior to starting to perform the surgeries. The implants had been designed differently from previous types of hip replacement devices, and surgeons needed to be much more precise about the way they implanted them than they'd ever needed to be before.

Since there was no evidence found saying that the implant device itself was to blame for the problems patients were having, no recall was ever issued. This leaves the way clear for them to put the implant back on the market once efficient methods of training are developed for doctors. Zimmer needed to develop a better way of teaching physicians the very precise skills required to do the hip replacement using the Durom Cup successfully.

No program was set up by Zimmer to follow a patient's progress once the implant was in place. People who demanded a product recall have cited this as a reason for their demands. However, most people feel that it isn't the manufacturer's place to have to police the usage of their products forever. Even so, there is another school of thought that believes that the manufacturer needs to take a more active follow-up role.

Physicians clearly blame the device for the problems that are popping up. They point to the fact that a knee replacement device manufactured by Zimmer is still being used in the United States even though Austrian doctors stopped using it just three years after it was introduced because it failed in almost 40% of the cases in which it had been used. It's easy to understand why doctors are feeling uneasy about using Zimmer products despite their previous reputation.

About the Author:

No comments: