Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Pain (1994)
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Event Date 10/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in the (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00023 , 3002806535-2019-00024.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 by the hospital that a patient underwent an initial right knee replacement procedure.Subsequently, a revision procedure due to pain was performed.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxford ph3 cementless fem sz m catalog #:154926 log #: 1545088, medical product: oxf uni cmntls tib sz c rm catalog #: 166575 log #: 1446230.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 by the hospital that a patient underwent an initial right knee replacement procedure.Subsequently, a revision procedure due to pain was performed.
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Search Alerts/Recalls
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