This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h9, h10.Correction: d4.H6: suggested component code: mechanical (g04) - femur.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product found part# 183122 was found in the package of part#183104.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to manufacturing issue.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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