It was reported that revision surgery was performed due to pain, weakness of the legs and hips, elevated cobalt and chromium levels, and fluid accumulations around the hip.The acetabular cup involed in this case was implanted on (b)(6) 2009, and the femoral head, modular sleeve and femoral stem were implanted on (b)(6) 2009.
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The devices reportedly utilised in this case were implanted in an off-label application in the usa, as the hemi-head (large diameter cocr femoral head) is only approved for use in the usa when attached to a smith & nephew femoral stem for articulation on native bone, not on an acetabular component (bhr acetabular cup).The bhr acetabular cup is fda approved for us only with a bhr resurfacing femoral head.
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