The product identification necessary to review manufacturing history was not provided.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.
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It was reported that patient underwent left total hip arthroplasty on (b)(6) 1986.Subsequently, patient was revised on (b)(6) 2003 due to unknown reasons.The trochanteric bolt, polyethylene liner, and modular head were removed and replaced.No further information has been provided.
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