This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.The following sections were updated: if follow-up, what type?, device evaluated by mfr, evaluation codes.Reserve sample from the same lot was evaluated and the reported event was confirmed.Testing was performed under standardized conditions and the sample tested showed the polymer powder was compact and the setting time was too long.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined at this time; further investigation has been initiated to address reported issue.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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