BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 6112439 · Received November 18, 2016

    Report

    Report Number
    3004153240-2016-00232
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 1, 2016
    Report Date
    November 18, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    UDI-DI
    M572TCR1211111021
    PMA / PMN Number
    K142161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762874 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC. M572TCR1211111021

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention