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 05/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign source: (b)(6).Concomitant medical products: medical product: oxf domed lat men brng sz 5 uk, catalog #: 161689, lot #: 3428009.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product discarded.
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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 aseptic loosening of the tibial component.
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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 aseptic loosening of the tibial component.
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Manufacturer Narrative
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(b)(4).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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