Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Pain (1994)
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Event Date 08/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf twin-peg cmntd fem sm pma catalog #: 161468 lot #: 328060, medical product: oxf uni tib tray sz b lm pma catalog #: 154720 lot #: 372340.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00711, 3002806535-2019-00712.The investigation is in process.Once the investigation is complete, 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 left knee procedure.Subsequently, the patient was revised due to pain and loosening.
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Manufacturer Narrative
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(b)(4).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 (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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Event Description
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It was reported that a patient underwent an initial left knee procedure.Subsequently, the patient was revised due to pain and loosening.
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Search Alerts/Recalls
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