Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 10/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr's were submitted for this event.Please see reports: 3002806535 - 2017 - 01065.3002806535 - 2017 - 01066.3002806535 - 2017 - 01067.(b)(4).Concomitant products: 161468 oxf twin-peg cmntd fem sm pma lot 769940.159532 oxf uni tib tray sz aa rm pma lot 721200.159570 oxf anat brg rt sm size 5 pma lot 032710.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported that a patient underwent an initial right knee procedure.Subsequently, the patient was revised due to unknown reasons.Patient was converted from partial to total knee system.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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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Search Alerts/Recalls
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