(b)(4).Concomitant product(s): a 00830001300, tm ankle talar component, 62416036n; 00830004300, tm ankle tibial base component, 77002854; 00830005300, tibial insert component, 62637225.Report source, foreign - the event occurred in (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01360, 0001822565 - 2018 - 01359.Remains implanted.
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