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 total hip arthroplasty on an unknown date in 2001.Subsequently, patient was revised on (b)(6), 2015 due to recurrent dislocations.The dislocations were caused by eccentric wear on the liner due to malpositioning of the cup during the initial surgery.No further information has been provided.
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