BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL

    MDR report key: 2782090 · Received October 3, 2012

    Report

    Report Number
    3004153240-2012-00084
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 7, 2012
    Manufacturer
    CONFORMIS
    Product Code
    HSH
    PMA / PMN Number
    K103117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WITH A TOTAL KNEE IMPLANT DEVELOPED AN INFECTION. REVISION SURGERY IS PLANNED. 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

    PATIENT WITH A TOTAL KNEE IMPLANT DEVELOPED AN INFECTION. REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITOTAL TOTAL KNEE REPLACEMENT SYSTEM HSH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R