(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Medical devices: item number: 157448, item name: m2a magnum head, lot #: 573060; item number: us157854, item name: m2a magnum cup, lot #: 451440; item number: 103202, item name: taperloc stem, lot #: 066890.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08143.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00203.
|