Model Number N/A |
Device Problems
Degraded (1153); Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - concomitant devices - vanguard cruciate retaining femoral component right 70mm catalog #: 183012 lot #: ni, polished finned tibial tray 75mm catalog #: 141254 lot #: ni g2 - report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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: 0001825034-2023-02317; 0001825034-2023-02318.H3 other text : investigation incomplete.
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Event Description
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It was reported that the patient underwent a right knee arthroplasty revision to address posterior knee subluxation of the tibial bearing approximately ten (10) years post-operatively.During the revision, the posterior medial tibial tray and distal medial femoral condyle appeared to be damaged from the subluxation.The surgeon preferred to avoid a total revision and only replaced the tibial bearing.Attempts have been made; however, no additional information is available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02318-1.Visual examination of the provided pictures identified sign of use, and both bearing and femoral condyle noted to be worn.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right knee arthroplasty malalignment as noted with posteromedial metal-on-metal contact and resulting knee varus.Damage to the articular tibial bearing.A definitive root cause cannot be determined.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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