(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42502606801, femur cemented cruciate retaining (cr) standard left size 10, lot #: 64284726.42532007501, tibia cemented 5 degree stemmed left size f, lot #: ni.Report source: event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00064, 0001822565 - 2020 - 00709.
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This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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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