Saturday, February 7, 2009

The Future of the Zimmer Durom Cup Replacement Hip Implant

By Maxwell Schmickman

The Zimmer Durom Cup Replacement component was used in over 12,000 hip replacement surgeries in the United States from its approval in 2006 through July, 2008. These devices are made of only one piece of material, and their design differs radically from the 3-part implants which were their predecessors. During the period of time from 2003 to 2006, hundreds of implant surgeries were successfully performed in Europe, and American physicians were impressed. Unfortunately, as many American patients started having problems with their implants, doctors lost their faith in them.

Patients started complaining of pain in their hips. Although there is some pain to be expected for the first few months after hip replacement surgery, Durom Cup recipients were starting to complain of problems well after the three-month recovery period. Doctors are now convinced that revision surgery will be needed in almost 5.7% of the patients who received the transplants prior to July, 2008.

In July, 2008 Zimmer voluntarily pulled their Durom Cup Replacement components from the American market and advised physicians not to use them. By August, however, the devices were back on the market and available to those physicians who completed a new Internet training program to learn the correct technique for implanting them. These new and improved techniques are supposed to cut the failure rate of the implant surgeries dramatically. However, the damage was already done, and many doctors had become skeptical about the Durom Cup Replacement to the point where they refused to take the extra training required for its use.

Due to the problems so many patients have had with the Zimmer Durom Cup Replacement, there are many pending lawsuits against the company, including a class action suit filed in the state of Indiana by stockholders. At the end of the 3rd quarter of 2008, Zimmer announced it had set aside $47.5 million to cover the various lawsuits that were being brought against it. Although they still don't feel their product is to blame, because they found it to be in no way defective, they still accept some of the liability for their failure to provide adequate training for doctors to teach them new implantation techniques.

Product liability attorneys are encouraging hip replacement patients to file suit if they are still having hip pain more than three months after their surgery, if there has been any loosening in their artificial joint, or if their doctors have recommended revision surgery to correct their problems. Most states have laws on the books that entitle patients to compensation if they have experienced pain, additional medical expense, and loss of wages caused by a defect in the prosthetic device they are using.

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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