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.
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 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.
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 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.
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 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.
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 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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