This follow-up report is being submitted to relay additional and/or corrected information.The product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The raw material certificate was reviewed with no anomalies noted.It was reported that the patient had a fall event prior to the revision.If and to what extent the fall event caused or contributed to the revision surgery remains unknown.It can be assumed that due to the fall event, the patient suffered an implant fracture and a re-fracture of the bone.However, due to a lack of information, a definitive root cause cannot be determined.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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