During a shoulder arthroplasty, contaminate was found under the metal plate on the back of the humeral trial heads.After the procedure, all the trials were then taken apart, decontaminated again, reassembled to be used for the next case that was postponed by two hours for this second decontamination of the trials.
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(b)(4).This follow-up report is being submitted to relay additional information.Device history records were reviewed and no discrepancies were found.Product was visually examined.Externally, the products do not appear to have any bioburden on the head or plate.To further investigate, several provisionals (both versadial and comprehensive) were disassembled.Upon disassembly, there was notable staining indicative of bioburden under the plate; therefore, the complaint is confirmed.Investigation results concluded that the root cause of the complaint is a design related issue.A design change has been initiated to address the reported event.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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