(b)(4).Concomitant medical products: item number :650-1057 item name cer bioloxd option hd36mm, lot #: 2957963.Item number :650-1064 item name cer option type 1 tprsleve -6, lot #: 2959033.Item number: 51-106110 item name tprlc 133 mp type1 pps so11.0, lot #: 6473490.Item number: 00625006520 item name bone scr 6.5x20 self-tap ,lot # :64032379.Item number: 00625006525 item name bone scr 6.5x25 self-tap, lot #: 64386886.The device will not be returned for analysis, remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.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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