BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION CS TRIAL INSERT 10MM SIZE 5 STD RIGHT

    MDR report key: 11957033 · Received June 8, 2021

    Report

    Report Number
    3010536692-2021-00317
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    April 8, 2021
    Report Date
    August 1, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HWT
    UDI-DI
    M684E310510R1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FDA SAFETY REPORT ID# (8)(4). FDA REPORT# MW5101036.

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING RIGHT TOTAL KNEE ARTHOPLASTY 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). FDA REPORT# MW5101036.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859894 EVOLUTION CS TRIAL INSERT 10MM SIZE 5 STD RIGHT KNEE INSTRUMENT HWT MICROPORT ORTHOPEDICS INC. E310510R NI M684E310510R1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention