BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA MC VE ASF R 11MM 8-11/GH

    MDR report key: 23696751 · Received December 2, 2025

    Report

    Report Number
    3007963827-2025-00482
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 3, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024468504
    PMA / PMN Number
    K150090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. THE EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: SPIKED KEEL RIGHT SIZE G OSSEOTI TIBIA: CATALOG#42535007902, LOT#67458887. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS PER HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT SEAT ON THE TIBIAL TRAY. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ADDITIONAL COMPLICATION. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810708 PERSONA MC VE ASF R 11MM 8-11/GH PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 67366472 00889024468504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.