Zimmer Durom Cup Problems Highlight Need for Joint RegistryJul 29, 2008 | Parker Waichman LLP
Hundreds of patients receiving Zimmer Durom Cup hip implants in the U.S. have been experiencing serious problems since the device was introduced in 2006. But it wasn't until this past April, when a prominent surgeon went public with his concerns about the Durom Cup, that physicians learned of the widespread nature of the complaints. Now, patient advocates are calling for the creation of a national database, called a joint registry, that tracks how patients with artificial hips and knees are doing. Such a system, they argue, would quickly alert doctors and federal regulators to devices that have a high failure rate, possibly sparing tens of thousands of patients from severe, painful injuries.
The Durom Cup has been implanted in more than 12,000 U.S. patients since its introduction. The Durom Cup was designed for use in young, active patients who are likely to outlive a conventional hip prosthesis. But last year, Dr. Lawrence Dorr, a highly experienced orthopedist and Zimmer consultant, realized something was very wrong with the Durom Cup.
Within months of receiving the component, many of Dr. Dorr's patients were back in his office, suffering from crippling pain. X-rays of patients who received defective Durom Cups showed that the socket was separating from bone, rather than fusing with it. For patients, who had been told their new hips might last 15 to 20 years, the defect meant they would have to undergo an additional excruciating surgery to have their implant replaced.
Dr. Dorr took his concerns to Zimmer in early 2008, but he was ignored. The company actually tried to blame Dr. Dorr's surgical technique for his patients problems - despite the fact that he has decades of experience doing hip implants. In frustration, Dr. Dorr took his concerns to the American Association of Hip and Knee Surgeons, and found that many other surgeons had similar experiences with the Durom cup. Finally, Zimmer bowed to the pressure created by Dr. Dorr and began an investigation.
Zimmer's investigation revealed that at some clinics, the Durom Cup failure rate was higher than 5 percent. Finally, in July 2008, Zimmer suspended sales of the defective component.
Critics argue that it never should have taken so long for the Durom Cup's problems to become apparent. And in many countries it would not have. Those countries, including Australia, Britain, Norway and Sweden, use joint registry databases to track the performance of artificial joint components. If the U.S. had such a database, Zimmer might have been forced to take the Durom Cup off the market long ago.
According to The New York Times, The Food and Drug Administration is charged with monitoring devices like artificial joints. But that system is often overwhelmed by the vast number of products it monitors and because doctors often do not report problems. Medicare, which pays for about half the hip and knee implants in this country, rebuffed a proposal two years ago from a medical group to support a joint database. It said it was not the agency’s job to gather such data — despite the considerable savings in taxpayer dollars that might come from reducing the number of do-over surgeries.
There are many reasons given for the failure of the U.S. to create a joint implant registry, ranging from the fragmentation and expanse of the healthcare system to the expense involved in such an effort. However, some critics believe a more sinister force is at work - specifically the financial arrangements between implant makers and many orthopedic surgeons. In any registry system, it would be up to physicians to report device problems. Some physicians might be reluctant to report problems with a device if they are receiving compensation from its manufacturer.
If such attitudes are blocking the creation of a joint implant registry, it would not be the first time surgeons were influenced by the payments they receive from implant makers. Last year, several major manufacturers, including Zimmer and Smith & Nephew, agreed to pay $310 million to settle civil charges and resolve a Department of Justice investigation into whether the firms paid illegal inducements to get some doctors to use their products.