Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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Pcf and medical records received.After review of medical records, it was indicated the patient complains of discomfort.It was also indicated that the patient has had multiple dislocation.The patient was then revised due to failed tha and adverse local tissue reaction.Operative note reported that there was pseudotumor and some necrotic-appearing material.The trunnion showed trunnions.There was blackened material on both the stem as well as inside of the ball.Doi: (b)(6) 2007, dor: (b)(6) 2019; left hip.
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