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.
Even though Zimmer knew about the problem as early as January, 2008, it wasn’t until July of that same year that they finally suspended American sales of the device. They chose to spend the interim time looking into the allegations instead of eliminating the problem. They were skeptical that the implants could be defective as doctors were saying, because they had been used so successfully in Europe. Since they felt they needed to look elsewhere for the problem, they didn’t want to take the devices off the market until they were sure what the culprit was.
Zimmer employees did a detailed study of the cases of 3,100 patients who had been given a Durom Cup implant. Their findings indicated that there was no problem with the technology used to build the implants. Instead they concluded that the problem lay in the fact that the surgeons who had performed the procedure were still using older implant methods that had worked with the devices that had preceded the cup. With the Durom Cup, however, surgeons needed to learn more precise methods prior to ever attempting to do an implant. Without this training, they were unable to perform successful surgeries.
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 have left no doubt in anyone’s mind that they consider the whole problem to be related to defects within the Durom Cup itself. In the defense of the doctors’ point of view, Zimmer does still market a knee replacement device in the U.S. even though Austrian doctors quit using it a number of years ago, because it failed in 40% of the patients it was used to help. These blemishes on Zimmer’s reputation have left doctors somewhat skeptical about how well their products will work.
