Should Zimmer Holdings, Inc. Have Recalled the Durom Cup?
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.
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.
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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