This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was not confirmed.The part passed inspection of the outer profile with the exception of some deformed areas where the liners are damaged.This damage likely occurred during the procedure.Product likely left biomet control conforming.Dhr was reviewed and no discrepancies were found.Complaint history review identified an issue which is being addressed in (b)(4).Device analysis indicated that the device met specification.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.Zimmer biomet complaint: (b)(4).
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