DePuy Orthopaedics Inc. announced Thursday it will discontinue sales of Ultamet® Metal-on-Metal Articulation and Complete™ Ceramic-on-Metal Acetabular Hip System worldwide. The discontinuation will be effective Aug. 31. The decision is not related to safety or efficacy and is not a recall, according to a company statement. The decision to discontinue Ultamet and Complete was made in conjunction with an ongoing review of DePuy’s product portfolio, according to the statement. Other worldwide product discontinuations will be announced throughout 2013 and 2014. DePuy made the decision to discontinue these products because of low clinician use of Ultamet and Complete, the availability of other options that meet the clinical needs of patients, and proposed changes in FDA regulation of the entire class of metal-on-metal products. Clinician use of ceramic-on-metal and metal-on-metal bearings is extremely low and not expected to increase. In the United States and Europe in 2012, metal-on-metal bearings comprised less than 2 percent of the bearings implanted. This represents a 90-percent decline in industry sales since 2007, the company said, based on industry surveys and other estimates. Industry sales of ceramic-on-metal bearings have been low since their introduction to the market, and Ultamet and Complete brands now represent less than 1 percent of DePuy bearings sold in these markets. Advancements in polyethylene bearing technology and the recent approval of next generation options that meet the clinical needs of patients also contributed to this decision, the company said. Physician preferences have shifted toward metal-on-polyethylene, ceramic-on-polyethylene and ceramic-on-ceramic bearings. Another factor in the decision to discontinue Ultamet is the proposed regulatory change by the U.S. Food and Drug Administration, which announced in January plans to require all metal-on-metal hip replacements with existing 510(k) clearances to be approved through the Premarket Approval process. Ultamet was first cleared for sale through the 510(k) process in 2000. DePuy will continue to invest in new bearing technologies like ceramic and polyethylene technologies, according to the statement.
