(b)(4).Concomitant medical products: associated products: item number:51-107220,item name: tprlc 133 mp type1 pps ho 22.0, lot number:3616830, item number:110017109,item name:g7 finned 4 hole shell 64h, lot number:7115768, item number:98-b001-009-41,item name:unknown product, lot number: unknown, item number:30104008, item name:g7 vit e neutral lnr 40mm h, lot number:65100260, item number:650-1058, item name:cer bioloxd option hd 40mm, lot number:3096108, item number:650-1067, item name:cer option type 1 tpr sleve +3, lot number:3035290, item number:650-1058, item name: cer bioloxd optionhd 40mm, lot number:3095934.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00481.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 3500a will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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