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 05/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: unk oxford femoral component, catalog #: unk, lot #: unk, medical product: unk oxford tibial component, catalog #: unk, lot #: unk.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00473, 3002806535-2019-00474.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not return.
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Event Description
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, a revision procedure was performed due to loosening.
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Event Description
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Revision due to loosening.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product:oxf twin-peg cmntd fem lg pma catalog #: 161470 lot #: 2992011, medical product: oxf uni tib tray sz d rm pma catalog #: 154725 lot #: 2971276.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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 replacement procedure.Subsequently, a revision procedure was performed due to loosening.
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Search Alerts/Recalls
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