Was there a Zimmer Durom Cup Recall or Not?
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by: Maxwell Schmickman
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Date: Fri, 22 May 2009 Time: 4:16 PM
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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.
In July, 2008, Zimmer finally suspended sales in America which was about 6 months later than the move should have happened per most interested parties. Instead of pulling the cups from the market in January when they became aware of problems, Zimmer left them on the market while they investigated what was going on. Since the implants had been used so successfully in a multitude of surgeries in Europe, they couldn't fathom that the same devices were defective when used in the U.S. They felt the reason for the problems lay elsewhere, and they were reluctant to make a major move that would undermine company profits until they'd looked into the situation further.
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.
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.
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 clearly blame the device for the problems that are popping up. They point to the fact that a knee replacement device manufactured by Zimmer is still being used in the United States even though Austrian doctors stopped using it just three years after it was introduced because it failed in almost 40% of the cases in which it had been used. It's easy to understand why doctors are feeling uneasy about using Zimmer products despite their previous reputation.
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