(b)(4), multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 02792, 0001825034 - 2023 - 02800.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.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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