BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DUR REG FLUTED STEM13X155MM

    MDR report key: 22663182 · Received July 30, 2025

    Report

    Report Number
    0002249697-2025-00744
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    January 21, 2021
    Report Date
    July 30, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327045000
    PMA / PMN Number
    K973164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: BROKEN TIBIAL STEM. TIBIAL COMPONENTS REMOVED. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444503 TI DUR REG FLUTED STEM13X155MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327045000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H