Reasons for a Zimmer Durom Cup Recall

by Maxwell Schmickman

Stockholders, doctors, patients, and attorneys are still debating the handling of the sale of Zimmer Durom Cup hip implants in the United States. Although these devices were used successfully in Europe for three years prior to being approved in the U.S., their track record in America has been less than stellar. Many contend that the company was slow to respond to the problems that were occurring and negligent in informing the public about what was going on. Many feel that a recall should have been issued on the defective cups, but Zimmer has not done so.

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.

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.

Zimmer never issued a formal recall of the Durom Cup, because they found no evidence of any of the failures being caused by defects within the device. They are planning to get the implant back on the market just as soon as they come up with a way to train doctor’s to do the hip replacement surgery with the precision that is necessary.

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 have left no doubt in anyone’s mind that they consider the whole problem to be related to defects within the Durom Cup itself. In the defense of the doctors’ point of view, Zimmer does still market a knee replacement device in the U.S. even though Austrian doctors quit using it a number of years ago, because it failed in 40% of the patients it was used to help. These blemishes on Zimmer’s reputation have left doctors somewhat skeptical about how well their products will work.

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Published by: Maxwell Schmickman on March 30th, 2009 | Filed under Legal



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