BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA

    MDR report key: 16726462 · Received April 12, 2023

    Report

    Report Number
    3010536692-2023-00070
    Event Type
    Injury
    Date Received
    April 12, 2023
    Report Date
    June 11, 2023
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684KTCCNP201
    PMA / PMN Number
    K960617
    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 PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: 5050346. SIDE: L . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCT NO REVISED: PRODUCT ID: KPONTP32, ADVANCE ONLAY ALL POLY PATELLA 32MM TRIPEG, LOT: 177967, QTY: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008918 ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. KTCCNP20 1779216 M684KTCCNP201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention