(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 00771301600, lot: 61454594, modular femoral stem size 16.25.Part: 00784802200, lot: 61805988, modular neck b 12/14 neck taper.Part: 00801803202, lot: 61829218, femoral head sterile product 12/14 taper.Part: 00620005820, lot: 61374944, shell porous with holes 58 mm o.D.Part: 00625006525, lot: 61825084, bone scr 6.5x25 self-tap.Part: 00625006530, lot: 61850953, bone scr 6.5x30 self-tap.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01741, 0001822565-2021-01742, 0002648920-2021-00168, 0002648920-2021-00361.
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It was reported the patient underwent a left hip procedure and subsequently, was revised 8 years later due to in-vivo corrosion, elevated metal ions, necrotic tissue and failure to osteointegrate.No further event information available at the time of this report.
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