BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL

    MDR report key: 4961008 · Received July 31, 2015

    Report

    Report Number
    3004153240-2015-00147
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 6, 2015
    Manufacturer
    CONFORMIS
    Product Code
    OOG
    PMA / PMN Number
    K103117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TIBIAL LOOSENING WAS REPORTED FOR PT WITH A TOTAL KNEE IMPLANT. IT WAS REPORTED THAT THE PT HAD A MILD METAL ALLERGY. REVISION SURGERY OCCURRED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    TIBIAL LOOSENING WAS REPORTED FOR PT WITH A TOTAL KNEE IMPLANT. IT WAS REPORTED THAT THE PT HAD A MILD METAL ALLERGY. REVISION SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498821 ITOTAL TOTAL KNEE REPLACEMENT SYSTEM OOG CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention