(b)(4).Event date: unknown day in september, 2020.Implant date: unknown day in september, 2020.Explant date: unknown day in september, 2020.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03877.
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No product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided for the stem provisional.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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