On Tuesday, Zimmer Holdings, Inc. suspended sales of its Durom Cup artificial hip component in the U.S. This action was taken after the device manufacturer reviewed a number of reports from surgeons who experienced a higher than expected rate of Zimmer Durom Cups loosening and requiring total hip replacement revisions.
Zimmer announced that they will develop new product labeling which provides more comprehensive instructions about special surgical techniques that doctors should use to reduce the risk of problems after they perform a total hip replacement. The company will also implement a surgical training program in the U.S. and will only allow doctors to implant the Durom Cup after they have completed the training.
The Zimmer Durom Cup was introduced in Europe in 2003 and was first approved in the United States in 2006. The Durom Acetabular Component is a monoblock of cobal chromium alloy. It is designed for use in combination with Zimmer’s Metasul Metal-on-Metal Tribological Solution Large Diameter Heads (LDH). The company states that the newer type of artificial hip addresses some of the more common issues with traditional hip replacement components, such as wear of the bearing, range of motion and instability.
The Zimmer Durom Acetabular Component has been implanted in over 12,000 people in the United States since 2006. While very few problems have been reported in Europe, a number of U.S. surgeons have complained that patients developed post-hip surgery problems or loosening of the parts, often requiring additional surgical revisions.
In May 2008, Zimmer sent a letter to healthcare providers indicating that they were initiating an investigation into the complaints surrounding their Durom artificial hip component. After reviewing data on over 3,100 cases, Zimmer concluded that the technology and design parameters of the Durom Cup require a higher degree of precision than the more common hip replacement surgical techniques used in the U.S. Therefore, they have decided that additional instructions and surgical training is necessary before this product is used.
In a statement released on their website, Zimmer states that a thorough check of the Durom Cup, including evaluation of the manufacturing processes, design specifications and product documentation, failed to reveal any evidence of a defect in the artificial hip part.