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Reasons for a Zimmer Durom Cup Recall
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.
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.
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.
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