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.
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.
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 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. - 15683
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.
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.
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 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. - 15683
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