The follow up report is being submitted to relay additional information received complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned complaint sample shows the tm is smeared and shows embedded bio debris.Dimensional analysis was performed on the returned device, and device was found to be conforming to print specifications.Cmm report shows that all features are found to be confirming except one taper feature.However, the features that interface with the baseplate inserter were measured 100% on cmm at the time of manufacture.This was likely due to damage caused during the case, when the device jammed.Dhr was reviewed, and no discrepancies were found.A definite root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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