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.
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.
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.
Part of the problem resulting in the public demand for recall is that no follow-up procedures were put in place by Zimmer in order to track the progress of patients using their implants. Some may argue that it isn't their job to police the product after it has been implanted, but others feel that if they made it, they should continue to be responsible for its performance.
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. - 15995
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 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.
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.
Part of the problem resulting in the public demand for recall is that no follow-up procedures were put in place by Zimmer in order to track the progress of patients using their implants. Some may argue that it isn't their job to police the product after it has been implanted, but others feel that if they made it, they should continue to be responsible for its performance.
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. - 15995
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