BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 5036544 · Received August 27, 2015

    Report

    Report Number
    3004153240-2015-00159
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 27, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFECTION WAS REPORTED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS. 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

    INFECTION WAS REPORTED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568780 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention