This follow-up report is being submitted to relay additional information.Updated: date of report, event, pma/510k, if follow-up, what type, device evaluated by mfr, device manufacture date.The following section has been corrected: device code.Reported event was unable to be confirmed.A femoral head provisional 12/14 was returned.Visual examination identified gouges and scratches, consistent with use, on the taper and the outer spherical surface.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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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