(b)(4).D10: 00801803202 femoral head sterile product do not resterilize 12/14 taper 61847117; 00620205622 shell porous with cluster holes 56 mm 61601485; 00631005632 liner 10 degree elevated rim 32 mm i.D.For use with 56 mm o.D.Shell 61801130; 00625006530 bone scr 6.5x30 self-tap 61881314.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2023 - 00275; customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h6 proposed component code: mechanical (g04)-stem no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified no additional complaints for the stem, and no additional complaints for the reported part and lot combinations.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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