(b)(4).Concomitant medical products: unknown stem unknown.Unknown liner unknown.Unknown head unknown.Report source: foreign: canada.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01951.0001825034-2023-01952.0001825034-2023-01953.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.
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This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h6.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.It is unknown if any product exchange occurred during the arthrotomy at this time.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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