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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 11 states, "wear and/or deformation of articulating surfaces." 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 a patient underwent right total hip arthroplasty on (b)(6) 1992.Subsequently, the patient was revised on (b)(6) 2003 due to liner wear and bone deficit.During the procedure the shell, head, and liner were removed and replaced.
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