Zimmer biomet complaint: (b)(4).Devices were not returned to zimmer biomet, therefore the root cause cannot be determined.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of the complaint history identified additional complaints that were investigated, and it was determined that no further action is required due to the time frame in which they were manufactured.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.This report is being submitted late as it has been identified in remediation.
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