(b)(4).Concomitant medical products: 00801803202-femoral head sterile product do not resterilize 12/14 taper-61484661, 00771101200-ml taper sz12.5 std offset-61422470, 00620005422-shell porous with cluster holes 54 mm o.D.- 61439125, 00625006530-bone scr 6.5x30 self-tap-61445389, 00630505032-liner standard 32 mm i.D.For use with 50/52/54 mm o.D.Shells-61405092, 0022320128-cable cerclage cable with crimp 1.8 mm dia.635 mm length-61251774.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00407, 0001822565-2021-00377, 0002648920-2022-00081 and 0002648920-2022-00083.Reported event was confirmed via medical records reviewed by a health care professional.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.
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