(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01279, 0001825034-2021-01280, 0001825034-2021-01281, 0001825034-2021-01282, 0001825034-2021-01283, 0001825034-2021-01284.Medical product: oss avl yoke 12mm item# 161075 lot# 382130; oss avl mod tib plate oss tape item# 161065 lot# 690080; oss avl tib bearing 12mm item# 161068 lot# 809890; oss tib blk aug 10x63/67 univ item# 150426 lot# 105590; oss avl poly tib bushing set item# 161071 lot# 490920; oss poly femoral bushings item# 150477 lot# 499870.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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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