Stockholders, doctors, patients, and attorneys are still debating the handling of the sale of Zimmer Durom Cup hip implants in the United States. Although these devices were used successfully in Europe for three years prior to being approved in the U.S., their track record in America has been less than stellar. Many contend that the company was slow to respond to the problems that were occurring and negligent in informing the public about what was going on. Many feel that a recall should have been issued on the defective cups, but Zimmer has not done so.
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.
Since there was no evidence found saying that the implant device itself was to blame for the problems patients were having, no recall was ever issued. This leaves the way clear for them to put the implant back on the market once efficient methods of training are developed for doctors. Zimmer needed to develop a better way of teaching physicians the very precise skills required to do the hip replacement using the Durom Cup successfully.
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.
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