(b)(4).This event was initially reported under biomet orthopedics llc facility number, report reference: 0001825034-2019-01276.Multiple mdr reports were filed for this event, please see associated report: 3002806535 -2019 - 00298, 3002806535 -2019 - 00300.Concomitant medical products: oxf uni tib tray sza rm/ll pma item# 154719 lot# 2154719, oxf anat brg rt sm size 3 pma item# 159568 lot# 428720.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.Remains implanted.
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