Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Type
Injury
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Event Description
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It was reported that the patient is being considered for a knee arthroplasty revision to address pain and instability approximately three (3) years post-operatively.However, no revision procedure has been reported to date.Attempts have been made; however, no additional information is available.
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Manufacturer Narrative
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(b)(4) d10 - concomitant devices - unknown zimmer femoral component catalog #: ni lot #: ni, unknown zimmer tibial tray catalog #: ni lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-02329.H3 other text : insufficient information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-02329, 0001822565-2023-02331, 0001822565-2023-02467.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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