BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 4102625 · Received September 11, 2014

    Report

    Report Number
    3004153240-2014-00127
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K131019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGERY IS PLANNED TO REMOVE EXCESS CEMENT PARTICLES IN THE JOINT. POLY INSERTS MAY BE EXCHANGED DURING THE PROCEDURE. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    SURGERY IS PLANNED TO REMOVE EXCESS CEMENT PARTICLES IN THE JOINT. POLY INSERTS MAY BE EXCHANGED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562455 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention