BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL TIBIAL INSERT

    MDR report key: 11737768 · Received April 27, 2021

    Report

    Report Number
    MW5101036
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 26, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT TOTAL KNEE ARTHROPLASTY THE TRIAL PLASTIC INSERT BROKE WHILE BEING PLACED INSIDE THE PATIENT'S RIGHT KNEE. PIECES WERE REMOVED AND X-RAY WAS OBTAINED. NO FOREIGN OBJECTS SEEN ON X-RAY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626703 TRIAL TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH MICROPORT ORTHOPEDICS INC. 10 MM TIBIAL TRIAL, 5R

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other