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 04/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf uni tib tray sza rm/ll pma, catalog #: 154719, lot # 056950: medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 441720.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00446 3002806535-2019-00447.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 pain and loosening.
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Manufacturer Narrative
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(b)(4).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 pain and loosening.Information received that the femoral and tibial components were well fixed, the bearing was popping out.
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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 right knee procedure.Subsequently, the patient was revised due to pain and loosening.Information received stated that the femoral and tibial components were well fixed, the bearing was popping out.
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Search Alerts/Recalls
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