Thursday, January 29, 2009

Was there a Zimmer Durom Cup Recall or Not?

By Maxwell Schmickman

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.

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.

Doctors are convinced that the problem with the hip replacements lies in the defective technology of the Durom Cup and not themselves. Similar problems related to a knee replacement device which is also manufactured by Zimmer has left them skeptical about using any Zimmer products. A knee replacement device is still being used in the U.S. even though it was banned in Austria several years ago because of its high number of failures. Doctors are getting afraid of trusting Zimmer technology as its reputation has become tarnished. - 15266

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