Reasons for a Zimmer Durom Cup Recall
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.
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.
Zimmer never issued a formal recall of the Durom Cup, because they found no evidence of any of the failures being caused by defects within the device. They are planning to get the implant back on the market just as soon as they come up with a way to train doctor’s to do the hip replacement surgery with the precision that is necessary.
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.
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.