Health & Fitness Tips

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

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.

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.

Zimmer compiled information from 3,100 implant surgeries in order to study the problem. They finally concluded that the implant itself was not to blame. Instead, they decided that American doctors hadn’t been trained to perform the special procedures necessary for successful implantation of the cups. These procedures were necessary due to the fact that the technology and design parameters of the Durom Cup required much more precise surgical procedures than those used with previous hip replacement devices.

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.

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 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.