BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 10775060 · Received November 2, 2020

    Report

    Report Number
    3004153240-2020-00198
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 2, 2020
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    UDI-DI
    M572TCR1111111021
    PMA / PMN Number
    K180906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAS SWELLING OF AN UNKNOWN CAUSE. THE SURGEON PLANS TO DO A WASHOUT OF THE PATIENT'S KNEE AND EXCHANGE THE POLY INSERTS IN THE PROCESS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SWELLING OF AN UNKNOWN CAUSE. THE SURGEON PLANS TO DO A WASHOUT OF THE PATIENT'S KNEE AND EXCHANGE THE POLY INSERTS IN THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238448 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC. TCR111111102 M572TCR1111111021

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention