242ebe6e-a32a-44a6-a9dc-aa3d34da313bUpdatePublished72023-09-072015-08-252022-03-17Not in Commercial Distribution03596010079367PrimaryGS1NA126544126544045483575Smith & Nephew, Inc.1UNIVERSAL BIPOLAR SHELL 44MM O.DfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)238-7538GUDID@SMITH-NEPHEW.COMK82372600033695Bipolar femoral head outer component, hemiarthroplastyAn implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.trueActiveKWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncementedtruefalse