BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE® PRIMARY FEMORAL SIZE 4 LEFT NONPOROUS

    MDR report key: 19638870 · Received June 28, 2024

    Report

    Report Number
    3010536692-2024-00389
    Event Type
    Injury
    Date Received
    June 28, 2024
    Report Date
    October 31, 2024
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    UDI-DI
    M684KFTCNP4L1
    PMA / PMN Number
    K972626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR / ASEPTIC LOOSENING TIBIA. SRNJR NUMBER: 5123099. SIDE: L. GENDER: M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184705 ADVANCE® PRIMARY FEMORAL SIZE 4 LEFT NONPOROUS KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. KFTCNP4L 1787157 M684KFTCNP4L1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention