Tags
BHR, Femur head, Food & Drug Administration, hip, Hip Replacement, hip resurfacing, NephewSmith, Premarket Approval
www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm127516.pdf.
Hip Prostheses
The Birmingham Hip Resurfacing (BHR) System, P040033, by Smith & Nephew Orthopaedics was approved on May 9, 2006 as a new expedited, first-of-a-kind premarket approval. The Birmingham Hip Resurfacing (BHR) System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR is called a resurfacing prosthesis because only the surface of the femoral head (ball) is removed to implant the femoral head resurfacing component. The BHR system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision. More information can be found at http://www.fda.gov/cdrh/pdf4/P040033.html.
WHERE ARE ALL THE POST MARKET REPORTS AS REQUIRED BY THE PMA????
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