Success and Failure with the Zimmer Durom Implant

Since 2006 over 12,000 hip replacement patients in the United States have been implanted with a Zimmer Durom Cup Replacement component. The one-piece design of these implants makes them radically different from the popular replacement devices of previous decades which were made in three parts. Doctors were impressed by the high success rate enjoyed by the cups in the European market in the three years prior to their approval in the United States. However, when the devices started failing in many American patients, physicians rapidly became alarmed.

A large number of implant patients started visiting their doctors and complaining of pain and disability in their hips. Of course, hip replacement is a major surgical procedure, and it takes a few months to fully recover, but Durom Cup Replacement patients started having mobility problems and pain after the normal three-month recovery period. Many of these patients have required revision surgeries to repair damage, and doctors believe that as many as 5.7% of all of the patients who received the implant prior to July 2008 will eventually need a revision.

After studying the problems from January through July, 2008, Zimmer finally pulled the Durom Cup Replacement device from American markets. After devising a new Internet training program for surgeons, the cup was reintroduced in August, 2008. Only doctors who complete the online training are now able to do the implant surgeries, because the extra training was designed to drastically cut down on the number of revisions that will need to be done. About half of all doctors have refused so far to take the training. They no longer have enough faith in the Zimmer product to go to any extra work in order to use it.

Patients who have experienced problems with their Zimmer Durom Cup Replacements are filing lawsuits against the company, and even stockholders have filed a class action lawsuit in Indiana stating that Zimmer should have notified shareholders about what was taking place long before they did. By the end of the 3rd quarter of 2008, Zimmer had set aside $47.5 millions to pay claims brought against them in these lawsuits. Although their testing did not find any defects in their product, they do admit that they were negligent in training doctors properly in its use.

Any patient who has unexplained hip pains longer than three months following the surgery, has had a doctor tell them that their Durom Cup Replacement device has loosened, or has been told that they need revision surgery are being urged by product liability lawyers to seek restitution. Under the laws of most states, patients with these problems are entitled to monetary compensation. Anyone who got a Durom Cup implant prior to July, 2008 may want to check with an attorney to see if they are eligible for compensation under these laws.

The Durom Cup Replacement device is once again being used in the U.S., but many physicians are still opting to use something else rather than risk the high rate of failure that has been associated with its use in this country. These doctors still believe that there is something intrinsically wrong with the design and are reluctant to spend the time it would take to be trained in the correct implant procedures. Patients need to look at the facts and decide for themselves if they want to take the risk, even with the improved odds brought about by better training. There is another way to look at the situation, though, and many patients are beginning to see the Durom Cup in a new light. After all, in spite of the 5.7% estimated failure rate for the device, it also has had an American success rate of 94.3%.

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Written by Maxwell Schmickman on December 9th, 2009 with no comments.
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