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.Date implanted - 1993.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 the patient underwent an initial right total hip arthroplasty on an unknown date in 1993.Subsequently, the patient was revised on (b)(6) 2015 due to instability and cup loosening as a result of osteolysis.The head, cup, and liner were revised.
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