Zimmer Durom Cup Sales Suspended
Published: July 25th, 2008 • Comments: 6
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.
Pingback by Zimmer Durom Cup Lawsuits — AboutLawsuits.com on 25 July 2008:
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Pingback by Zimmer Class Action Suit Filed After Durom Cup Problems : AboutLawsuits.com on 12 August 2008:
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Pingback by Zimmer Offers Training for Durom Hip Replacement Parts : AboutLawsuits.com on 29 September 2008:
[...] some doctors were experiencing hip failure rates of 5.7%. At that time, they indicated that the Zimmer Durom Cup would be reintroduced after revisions were made to the label and a new surgical training program was developed to [...]
Pingback by Zimmer Sets Aside Funds for Durom Hip Implant Lawsuits : AboutLawsuits.com on 27 October 2008:
[...] July 2008, Zimmer suspended sales of the Durom Acetabular Component, or Durom Cup, after confirming that some clinics using the hip implant were experiencing failure [...]
Pingback by Zimmer Durom Hip Lawsuit Reserves Increased to Cover Claims : AboutLawsuits.com on 30 January 2009:
[...] sales for the Zimmer Durom Acetabular Component, which is commonly referred to as a Durom Cup, were suspended in the United States after doctor’s reported high rates of patients who had their hip replacement fail after [...]
Comment by kim on 22 November 2009:
hip keeps dislocating