(b)(4).This follow-up report is being submitted to relay additional information.A ringloc bi-polar 28x49mm, part # 11-165222 from lot 249980, was returned and evaluated against the complaint.No identifiers are visible to be verified against the complaint.The returned assembly appears to be fully seated.The liner rotates freely within the cup.By viewing into the cut outs, it can be seen that the locking groove of the liner is engaging the ring.While holding the shell in 1 hand, the technician attempted to disengage the assembly, by pulling on the lip of the liner with a thumb from the other hand.The assembly could not be physically disengaged in the lab.Small nicks and dings are present around the rim of the cup.A small sliver of poly was observed inside one of the cutouts of the liner.Dhr was reviewed and no discrepancies related to the reported event were found.The investigation could not verify or identify any evidence of product contribution to the reported problem.The complaint could not be confirmed.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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