(b)(4).Concomitant product: item number 00885201436 item name elevated rim liner 36 mmi.D.Size mm for use with 60 mm o.D.Size mm shell lot # unk.Item number 00875708001 item name shell with cluster holes porous 80mm o.D.Size v v for use with v vshells lot # unk.Item number 00784301356 item name femoral stem beadedfullcoat 12/14 neck taper lm body ext.Offset size 13 13mm distal dia.160 mm length lot # unk.Item number 00625006525 item name bone scr 6.5x25 self-tap lot # unk.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00145, 0001822565 - 2022 - 00146, 0001822565 - 2022 - 00148.
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It was reported by the patient¿s wife that the patient underwent a hip replacement with zimmer biomet product nineteen (19) years ago.Patient now has bone spurs, tremor in right arm hand, skin rashes and sores that will not heal, constantly tires, has lost 2 inches in height, neck aches, hips are in pain, cannot sit, walk, or function.Having metal testing allergy done.Attempts have been made and additional information on the reported event is unavailable at this time.
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