The BIRMINGHAM HIP◊ Resurfacing is a metal-on-metal (MOM) hip implant system approved by the US FDA in 2006. The approval required a multicenter, prospective, post-approval study (PAS). Our purpose is to report the current minimum 10-year results. 253 patients (280 hips) had surgery between October 2006 and December 2009 at one of 5 sites. We report revisions, survivorship, EQ-5D, Harris Hip Score (HHS), radiographic findings, and metal levels including cobalt (Co) and chromium (Cr). The mean age at surgery was 51 years, 74% male, BMI 28, osteoarthritis 95%. 243 (87%) of hips have known outcome or 10-year minimum follow-up (fup). Prior to 10 years, 5 patients died, 20 hips were revised, and 37 hips did not complete 10-year fup.Introduction
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Post-market surveillance is necessary to ensure the safety and efficacy of newly introduced technologies and implants. The Birmingham Hip Resurfacing (Smith and Nephew, Inc., Memphis, TN) was the first hip resurfacing implant approved for use by the US FDA in May 2006. A prospective, multi-center postmarket approval study has been in progress to assess safety and efficacy of this implant. Patients meeting inclusion criteria were enrolled at five sites. Clinical evaluation and radiographs were obtained at 3 months and 1 year, and annually thereafter for a total of 10 years. Blood metal ion levels were measured at 1 year and 4 years.Background
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