BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II COCR TIBIAL BASE

    MDR report key: 7922245 · Received October 1, 2018

    Report

    Report Number
    3010536692-2018-01236
    Event Type
    Injury
    Date Received
    October 1, 2018
    Report Date
    October 1, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    PMA / PMN Number
    K960617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TREND WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO COMPONENT DISSOCIATION. REVISION NJR NUMBER: 4032958. SIDE: L. PRIMARY ASA: P2- MILD DISEASE NOT INCAPACITATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765146 ADVANCE(R) II COCR TIBIAL BASE KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. KTCC-NP40 1564104

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention