The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.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 an initial hip arthroplasty approximately 18-20 years ago.Subsequently, patient was revised on (b)(6) 2015 due to poly wear.During the procedure, the liner and femoral head were removed and replaced.No further information has been provided.
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