BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA® TRABECULAR METAL

    MDR report key: 23988209 · Received January 7, 2026

    Report

    Report Number
    0001822565-2026-00087
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 12, 2025
    Report Date
    April 29, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00889024230811
    PMA / PMN Number
    K172524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10 PN 42512100910 LN 65552273 PERSONA® VIVACIT-E. PN 42530007901 LN 66247299 PERSONA¿ NATURAL TIBIA¿ TRABECULAR METAL. PN 42540200038 LN 66241139 PERSONA® VIVACIT-E. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ FEMUR.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO PAIN AND INSTABILITY. PATIENT FELL AND WAS NOT DOING GREAT AFTER THE FALL. THERE WAS NOTHING BROKEN AND NO INJURY REPORTED. THE TIBIA, FEMUR, AND LINER WERE REVISED. THE PATELLA WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50948 PERSONA® TRABECULAR METAL PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. 66327510 00889024230811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11