BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL

    MDR report key: 2861700 · Received December 3, 2012

    Report

    Report Number
    3004153240-2012-00114
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 5, 2012
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K103117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY OCCURRED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURRED FOR PATIENT WITH A TOTAL KNEE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R