(b)(4).Concomitant medical products: item name: oxf anat brg lt md size 4 pma; item#: 159548 ; lot#: unknown, item name: oxf uni tib tray sz d lm pma , item#: 154724; lot#: unknown, item name: refobacin bc r 1x40 us; item#: 110034355; lot#: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00003, 3002806535 - 2023 - 00005.
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Devices are used for treatment.Medical records were not provided a definitive root cause cannot 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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