(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00472, 3002806535-2021-00474.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00472-1.3002806535-2021-00474-1.Product has not been returned for evaluation, and x-rays or medical notes have not been provided.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.These devices are used for treatment.No compatibility issues were noted.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history was assessed for three years prior to the notification date and identified 3 similar complaints for item 154926.There were no additional complaints against the lot 3981405.A review of complaint history was assessed for three years prior to the notification date and identified 2 similar complaints for item 159549.There were no additional complaints against the lot 3850890.A review of complaint history was assessed for three years prior to the notification date and identified no additional complaints for item 166574.There were no additional complaints against the lot 3831429.These part and lot combinations are not associated with any recalls at the time the search was conducted.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The likely condition of the devices when they left zimmer biomet is conforming to specification.The root cause of the reported event cannot be determined with the information provided if any additional information becomes available, then the complaint will be reopened and further investigated.
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