Has Zimmer Holdings, Inc. been negligent in not recalling their Durom Cup hip implant and unnecessarily slow in their reaction to the problems that have been occurring with it in the United States? Many of those who are personally involved, such as doctors, implant patients, stockholders, and attorneys contend that they have been. Despite the fact that the implant was used successfully in Europe for several years before being introduced in America, most people feel that Zimmer should have been quicker to inform the public about what was taking place. General consensus has it that the devices are defective and that the company should have issued an immediate recall when indicators pointed that way.
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 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.
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. - 15343
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 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.
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. - 15343
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