BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE STATURE® FEMUR SIZE 4 LEFT NONPOR

    MDR report key: 18796645 · Received February 28, 2024

    Report

    Report Number
    3010536692-2024-00113
    Event Type
    Injury
    Date Received
    February 28, 2024
    Report Date
    February 28, 2024
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    PMA / PMN Number
    K063731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY, DISLOCATION/SUBLUXATION/PROGRESSIVE ARTHRITIS. SIDE: L. REVISION NJR: 5163349. GENDER: F. EXPLANTED: FEMORAL COMPONENT, TIBIAL COMPONENT, TIBIAL LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733349 ADVANCE STATURE® FEMUR SIZE 4 LEFT NONPOR KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. KFTCNN4L 1764280

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention