BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 6193136 · Received December 21, 2016

    Report

    Report Number
    3004153240-2016-00254
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 21, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K131019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCORRECT PATELLA WAS IMPLANTED DURING TOTAL KNEE REPLACEMENT SURGERY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT. REVIEW OF THE DEVICE HISTORY RECORD FOR THE PATELLA LOT INDICATES THAT ALL PATELLA WERE PROPERLY IDENTIFIED AND ALL LABELING REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    INCORRECT PATELLA WAS IMPLANTED DURING TOTAL KNEE REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845257 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR