(b)(4).Concomitant medical products: catalog #: 00430001113, modular humeral stem 11 mm stem diameter 130 mm, lot # 60016771, catalog #: 00430204618, offset modular humeral head 18 mm head height 46 mm, lot # 73209000.Foreign source: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2022-02500, 0001822565-2022-02501.
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(b)(4).Reported event was confirmed as visual examination of the returned stem identified the dry blast finish has been worn at both proximal and distal ends of the humeral stem.The poly glenoid exhibits damage to all features with material missing.Bone cement remains on the backside.Also, the radiographs review identified the following: per report large periprosthetic lucency surrounding the humeral stem consistent with loosening.Overall fit of the humeral hardware is normal, however there is abnormal positioning of the humeral component related to the loosening causing eccentric positioning of the humeral stem tip.No other issues or abnormalities noted.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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