(b)(4).Concomitant medical products: comprehensive standard taper adapter, catalog#: 118001 lot#: 743940, comprehensive modular head, catalog#: 113034 lot#: 260990, comprehensive hybrid glenoid base, catalog#: 113952 lot#: 551410, comprehensive hybrid glenoid post, catalog#: pt-113950 lot#: 470030.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00503, 0001825034-2018-00504, 0001825034-2018-00505, 0001825034-2018-00506, 0001825034-2018-00507.No device or photos were received; therefore the condition of the component is unknown.Dhr was reviewed and no discrepancies relevant to the reported event were found.In the medical records, it is noted that the patient had pain and tenderness at 6 weeks postop; pain and tenderness at 3 months postop, instability/translation at 1 year postop, and no alleged issues at 2 years postop.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.Remains implanted.
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