Zimmer biomet complaint (b)(4).Complaint sample was evaluated and the reported event was confirmed.Product evaluation stated, "the fractured rim of the liner was worn to the point where the machine lines were removed.This suggests that the modular head was loading against the unsupported polyethylene above the rim.90 degrees from the fracture surface, there is plastic deformation of the rim that is consistent with impingement of the stem on the polyethylene liner.This, coupled with the proposed position of the modular head, suggests that the shell and liner may have been placed vertically and with a significant amount of version." dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event may have been due to the shell and liner being placed vertically and with a significant amount of version.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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