This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The insert was returned for investigation.The rim and the articulation surface are inconspicuous.On the backside, it is possible to see a series of scratches and metal transfer.Commonly observed metal transfers from the seating are also visible all around the taper region.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Review of the manufacturing records confirm that the insert was manufactured according to specification; therefore, it is not expected that the manufacturing process contributed to the reported issue.As the shell involved in the reported event was not returned, a product evaluation on this item could not be performed and an assembly test could not be carried out.Based on the available information, a definitive root cause for the reported event could not be established.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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