BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) DURAMER(R) REVISION CCK INSERT

    MDR report key: 8286419 · Received January 29, 2019

    Report

    Report Number
    3010536692-2019-00123
    Event Type
    Injury
    Date Received
    January 29, 2019
    Report Date
    January 29, 2019
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY (RIGHT). SRNJR NUMBER: (B)(4). FRP ASA: 1 - FIT AND HEALTHY. PRODUCTS NOT REVISED: ADVANCE II MODULAR TITANIUM TIBIA BASE SZ 1 STD NONPOROUS, KTTINP10, LOT: 1502504. ADVANCE REVISION FEMORAL SIZE 2 RIGHT NONPOROUS, KFCCNP2R, LOT: 1514917. FEMORAL STEM. TIBIAL STEM. FEMORAL WEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78175 ADVANCE(R) DURAMER(R) REVISION CCK INSERT KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. KIRV-214M 3913287401

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention