BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 4811803 · Received May 29, 2015

    Report

    Report Number
    3004153240-2015-00098
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 30, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    OOG
    PMA / PMN Number
    K120316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KNEE INSTABILITY WAS REPORTED FOLLOWING A TRAUMATIC INCIDENT. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    KNEE INSTABILITY SWAS REPORTED FOLLOWING A TRAUMATIC INCIDENT. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349331 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM OOG CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR