Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: m2a hi carbon hd std nk # item 11-163688 lot 985970; m2a-t univ 2-hole shl sz 41/54 # item 15-103684 lot 380410; taperloc por fmrl 10x140 # item 103204 lot 246950.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01397, 0001825034-2019-01400 and 0001825034-2019-01401.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported patient is experiencing unknown issues post-implantation.However, no revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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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.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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