ZMH » Topics » Durom Acetabular Component

This excerpt taken from the ZMH 10-K filed Feb 27, 2009.
Durom Acetabular Component
 
 
In July 2008, we temporarily suspended marketing and distribution of the Durom Acetabular Component (Durom Cup) in the U.S. to permit us to update product labeling to provide more detailed surgical technique instructions and implement an enhanced surgical training program in the U.S. We resumed marketing and distribution of the Durom Cup in the U.S. in August 2008.
 
During 2008, we received claims from a number of Durom Cup patients seeking reimbursement for costs and payments for alleged pain and suffering and we expect to receive additional similar claims. We recorded a provision for certain claims of $69.0 million in 2008, which represents management’s estimate of liability to patients undergoing revision surgeries related to the Durom Cup. The estimate is limited to revisions associated with surgeries occurring before July 2008 and within two years of the original surgery date. Any claims received outside of these defined parameters will be managed in the normal course and reflected in our standard product liability accruals.
 
We believe we lost hip product sales during 2008, in large part as a consequence of the events involving the Durom Cup. In addition, we expect that our entry into the U.S. hip resurfacing market has been hindered or delayed as the Durom Cup had previously been integral to our plans for entry into that market.
 
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