The FDA reviewed Smith & Nephew's pre-market approval application for its Birmingham metal-on-metal hip implant in 2006. At the same time, Wright Medical Group sought to block approval, alleging the clinical studies behind Smith & Nephew's device only included data from a single physician's case — the surgeon who invented the hip implant.
Despite the petition, the FDA awarded two pre-market approvals to Smith & Nephew, once in May 2006 and then in October 2006 for additional sizes, according to the report.
Wright Medical Filed Petition to Block Smith & Nephews Metal Implant FeaturedWritten by Jaimie Oh | July 24, 2012
Wright Medical Group had filed a citizen's petition to block Smith & Nephew's metal-on-metal hip implant from entering the market, according to a Mass Device report.
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