(b)(4).(udi): n/a.Concomitant medical products: catalog #: 00434901613, humeral stem 16 mm stem, lot #: 64448713.Catalog #: 115313, comp rvsr shldr glnsp, lot #: 612700.Catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr r, lot #: 005110.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02724 and 0001822565-2020-02727.
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(b)(4).Reported event was confirmed per the review of the x-rays, which identified superior dislocation of the humeral component and now abutment of the glenosphere and the calcar with associated bony resorption.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
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