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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.

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.

Zimmer compiled information from 3,100 implant surgeries in order to study the problem. They finally concluded that the implant itself was not to blame. Instead, they decided that American doctors hadn’t been trained to perform the special procedures necessary for successful implantation of the cups. These procedures were necessary due to the fact that the technology and design parameters of the Durom Cup required much more precise surgical procedures than those used with previous hip replacement devices.

Due to the fact that Zimmer found no intrinsic defects within the Durom Cup, they never issued a formal recall. Instead they removed it from the market planning to reinstate it as soon as they could formulate a method of teaching doctors the correct way to do the surgery with the precision they need to make the operation successful.

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.

Tags: Health & Fitness //