BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23878999 · Received December 23, 2025

    Report

    Report Number
    3007963827-2025-00535
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 4, 2025
    Report Date
    April 10, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; D9; G3; H2; H3; H6; H11. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED VERIFICATION OF CORRECT PART IDENTIFIERS FOR A RIGHT INSERT AND SIGNS OF USE INCLUDING DINGS AROUND THE EXTRACTION SLOT AND A FLARED DOVETAIL FEATURE. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO ITS PRINT SPECIFICATIONS. REPORTED EVENT WAS CONFIRMED BY COMPLAINT SAMPLE EVALUATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT LOCK INTO THE TIBIAL TRAY. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85259 PERSONA MC VE ASF R 11MM 8-11/GH PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 67271977 00889024468504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown