This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Device was returned and evaluated.Dimensional analysis of key features outside diameter and over all cup height verified product is correct size.In addition, the label content attached to mhr was verified, and found label to be correct for item, lot, size and description.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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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