BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 10MM LEFT

    MDR report key: 16751598 · Received April 17, 2023

    Report

    Report Number
    3010536692-2023-00085
    Event Type
    Injury
    Date Received
    April 17, 2023
    Report Date
    April 17, 2023
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS7S10L1
    PMA / PMN Number
    K093552
    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, PATIENT WAS REVISED DUE TO INFECTION REVISION NJR NUMBER: 5064705. SIDE: L . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCTS NOT REVISED: PRODUCT ID: LOT NUMBER: QTY: EFSRN7PL 1929852 1; ETPKN7SL 1923445 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319807 EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 10MM LEFT KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS7S10L 1895570 M684EIS7S10L1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention