Wednesday, February 4, 2009

The Zimmer Durom Cup Replacement Hip Implant

By Maxwell Schmickman

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.

Soon after the surgeries began in 2006, patients started revisiting their doctors with complaints. Naturally, they knew it would take a reasonable amount of time for full recovery, but they were experiencing pain well after the expected three-month recovery time. Upon examination, doctors determined that a large number of these patients needed revision surgery to correct problems. These physicians now believe that as many as 5.7% of all those receiving the Durom Cup Replacements prior to July, 2008 will need revisions.

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.

Patients who are experiencing unexplained hip pain more than three months after having hip replacement surgery, have loosening and slippage in their artificial hip implant, or require hip replacement revision surgery are being encouraged by product liability attorneys to file suit against the company. Per the laws in most states, patients are entitled to compensation for their pain and suffering, medical expenses, and lost wages due to defects in the Zimmer Durom Cup Replacements they received prior to July, 2008.

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%. - 15343

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