BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 2

    MDR report key: 11186660 · Received January 18, 2021

    Report

    Report Number
    3010536692-2021-00018
    Event Type
    Injury
    Date Received
    January 18, 2021
    Report Date
    January 18, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    UDI-DI
    M684KIMP420L1
    PMA / PMN Number
    K972770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT SUFFERED PAIN AND INSTABILITY. POLY WAS REMOVED AND A 30MM CCK POLY WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82618 ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 2 KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. KIMP420L 038A10637801 M684KIMP420L1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention