(b)(4).Report source: (b)(4).Unknown oxford tibial tray item#: unknown, lot#: unknown.Unknown oxford bearing item#: unknown, 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 - 2022 - 00338, 3002806535 - 2022 - 00339, 3002806535 - 2022 - 00340.
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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.Part and lot identification are necessary for review of device history records, neither were 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 report will be filed accordingly.
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