(b)(4).Concomitant medical products: 00626001800, cup positioner, 62207042.65875306001, shell with cluster holes porous 60 mm o.D.Size mm for use with mm liners with calcicoat ceramic coating, 63271280.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02181, 0001822565 - 2018 - 02182 (b)(6).Complaint sample was evaluated and the reported event was confirmed.Complaint sample was evaluated and the reported event was confirmed.A significant amount of force was applied with hand to disassemble the whole construct.Visual inspection of the shell identified impaction marks from the micro cap around apex hole.Visual inspection of the cup positioner identified superficial scratches on the handle body with no other damage.Visual inspection of the micro cap identified wear on the mating surface.The thread form of the cup positioner and the shell passed go and no go gages.The cup positioner has a field service age of 5.5 years.It is unknown how many times the positioner was used other shells.Dhr was reviewed and no discrepancies were found.The most likely root cause of the reported event can be contributed to the incompatible micro cap was used during the surgery.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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