This follow-up report is being submitted to relay additional information.Updated: b4, g4, g7, h2, h3, h6, and h10.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the device exhibits signs of repeated use (nicked & gouged).The tasp has fractured at the post.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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.
|