Zimmer Durom Cup Recall

Was there a Zimmer Durom Cup Recall or Not?

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.

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.

It has been stated that the public demand for product recall was partially based on the fact that Zimmer had no post-surgical procedures in place to follow up on the surgeries. It was also argued that this isn’t their job as manufacturer, anyway, although a lot of people are convinced that once a manufacturer markets a product it should take responsibility for it throughout its working life.

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.

-Maxwell Schmickman