BEUDAMED
    FDA Adverse Event Summary report: N

    PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20

    MDR report key: 4131197 · Received August 19, 2014

    Report

    Report Number
    3004983210-2014-00018
    Date Received
    August 19, 2014
    Report Date
    July 22, 2014
    Manufacturer
    TORNIER INC.
    Product Code
    KWH
    PMA / PMN Number
    K981194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    POSSIBLE ALLERGY TO THE IMPLANT HAS APPOINTMENT WITH THE ALLERGIST ON THURSDAY (B)(6) 2014. NEEDS A SAMPLE OR PORTION OF THE SILICON AND TITANIUM OF PRODUCT THAT IS IN THE FGT IMPLANT. POST OP SYMPTOM: SHE CAME OUT OF THE SURGERY IN PAIN (MORPHINE WAS ADMINISTERED IN THE RECOVERY ROOM). THEN PAIN AND SWELLING IN HER FOOT. SWELLING HAS REACHED ALL JOINTS. WITHIN 4 MONTHS OF SURGERY, THE DOWNWARD PROGRESSION STARTED. HAS HAD NUMEROUS TESTS DONE FOR RA, LUPUS, DIABETES, ETC. AND THEY HAVE ALL BEEN NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500257 PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20 NONE KWH TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1