(b)(4).The following sections could not be completed due to the part/lot information could be: catalog number - 00625006530.Lot number - 63213982.Expiration date - jan 31, 2026.Manufacture date ¿ feb 12, 2016.Or the part/lot information could be: catalog number - 00625006540.Lot number - 63308798n.Expiration date - ni.Manufacture date ¿ ni.Concomitant medical products: 00620205420 63379131 shell porous with multi holes 54 mm.00631005032 63569815 liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells.00801803203 63375195 femoral head sterile product do not resterilize 12/14 taper.00998201718 61699332 femoral stem - revision taper - nitrided cementless 17 mm diameter 185 mm stem length.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04026.
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This follow-up report is being submitted to relay additional information.Catalog number - 00625006540; lot number - 63308798n; expiration date - jan 31, 2026; udi - (b)(4).Manufacture date ¿ feb 12, 2016.Reported event was able to be confirmed via x-ray review.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to 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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