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.
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.
Using information taken from 3,100 implant surgeries, Zimmer put together a database of material so that their researchers could study the problem in detail. After a great deal of study, they determined that there was nothing wrong with the implant technology. What they found was that American doctors hadn't received adequate training prior to starting to perform the surgeries. The implants had been designed differently from previous types of hip replacement devices, and surgeons needed to be much more precise about the way they implanted them than they'd ever needed to be before.
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.
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 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. - 16004
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.
Using information taken from 3,100 implant surgeries, Zimmer put together a database of material so that their researchers could study the problem in detail. After a great deal of study, they determined that there was nothing wrong with the implant technology. What they found was that American doctors hadn't received adequate training prior to starting to perform the surgeries. The implants had been designed differently from previous types of hip replacement devices, and surgeons needed to be much more precise about the way they implanted them than they'd ever needed to be before.
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.
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 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. - 16004
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