(b)(4).Concomitant medical products: catalog# 211278, comprehensive segmental revision system seas humeral head 48x19, lot # unknown, catalog# 211228, comprehensive segmental revision system modular rgx aug - small, lot # unknown, catalog# 211232, comprehensive segmental revision system modular stem - 10x75mm, lot # unknown.Foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2018-03744, 0001825034-2018-03745, 0001825034-2018-03746.Remains implanted.
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This follow-up report is being submitted to relay additional information.Unique identifier (udi) #: (b)(4).Concomitant medical products : catalog# 211228, comprehensive segmental revision system modular rgx aug - small, lot # 664510.Catalog# 211232, comprehensive segmental revision system modular stem - 10x75mm, lot # 215950.Catalog# 211278, comprehensive segmental revision system seas humeral head 48x19, lot # 886950.Report source : foreign: canada.Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Root cause was unable to 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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