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Posts Tagged ‘hip replacement’

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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.

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.