Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Information (3190)
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Event Date 05/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz c lm pma.Catalog #:154722 lot #: 957490.Additional mdr report was filed for this event, please see associated reports: 3002806535-2019 -00513.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 knee procedure.Subsequently, the patient was revised due to tibial loosening and subsidence.Patient fell the day after surgery.
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Event Description
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It was reported that a patient underwent an initial knee procedure.Subsequently, the patient was revised due to tibial loosening and subsidence.Patient fell the day after surgery.
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Manufacturer Narrative
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(b)(4).The report of tibial loosening in (b)(4) cannot be confirmed with the available information.The reason for revision cannot be discussed further without additional information, including pre-revision radiographs, further patient information and provision of the revised components.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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