BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL

    MDR report key: 2953849 · Received January 31, 2013

    Report

    Report Number
    3004153240-2013-00009
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K103117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MFG TO SPECIFICATION.

    Description of Event or Problem · 1

    PT WITH A TOTAL KNEE IMPLANT REPORTED PAIN. SURGICAL INTERVENTION OCCURRED. DURING THE PROCEDURE, POLY INSERTS WERE EXCHANGED AND PATELLA IMPLANT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42234 ITOTAL TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention