Wednesday, February 4, 2009

Reasons for a Zimmer Durom Cup Recall

By Maxwell Schmickman

Has Zimmer Holdings, Inc. been negligent in not recalling their Durom Cup hip implant and unnecessarily slow in their reaction to the problems that have been occurring with it in the United States? Many of those who are personally involved, such as doctors, implant patients, stockholders, and attorneys contend that they have been. Despite the fact that the implant was used successfully in Europe for several years before being introduced in America, most people feel that Zimmer should have been quicker to inform the public about what was taking place. General consensus has it that the devices are defective and that the company should have issued an immediate recall when indicators pointed that way.

Even though Zimmer knew about the problem as early as January, 2008, it wasn't until July of that same year that they finally suspended American sales of the device. They chose to spend the interim time looking into the allegations instead of eliminating the problem. They were skeptical that the implants could be defective as doctors were saying, because they had been used so successfully in Europe. Since they felt they needed to look elsewhere for the problem, they didn't want to take the devices off the market until they were sure what the culprit was.

Zimmer employees did a detailed study of the cases of 3,100 patients who had been given a Durom Cup implant. Their findings indicated that there was no problem with the technology used to build the implants. Instead they concluded that the problem lay in the fact that the surgeons who had performed the procedure were still using older implant methods that had worked with the devices that had preceded the cup. With the Durom Cup, however, surgeons needed to learn more precise methods prior to ever attempting to do an implant. Without this training, they were unable to perform successful surgeries.

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.

Part of the problem resulting in the public demand for recall is that no follow-up procedures were put in place by Zimmer in order to track the progress of patients using their implants. Some may argue that it isn't their job to police the product after it has been implanted, but others feel that if they made it, they should continue to be responsible for its performance.

Doctors are convinced that the problem with the hip replacements lies in the defective technology of the Durom Cup and not themselves. Similar problems related to a knee replacement device which is also manufactured by Zimmer has left them skeptical about using any Zimmer products. A knee replacement device is still being used in the U.S. even though it was banned in Austria several years ago because of its high number of failures. Doctors are getting afraid of trusting Zimmer technology as its reputation has become tarnished. - 15438

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