Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 12/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00034, 3002806535-2019-00036.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 that a patient underwent an initial right knee procedure.Subsequently, the patient was revised due to unknown reasons.
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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.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Medical product: oxf anat brg rt md size 3 pma catalog #: 159575 log #: 206220.Medical product: oxf twin-peg cmntd fem md pma catalog #: 161469 log #: 904520.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 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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Search Alerts/Recalls
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