BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS TMJ IMPLANT

    MDR report key: 4949860 · Received July 23, 2015

    Report

    Report Number
    MW5044878
    Event Type
    Injury
    Date Received
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD A BILITERAL TMJ JOINT REPLACEMENT WITH TMJ CONCEPTS IN 2002, THEY WERE REMOVED IN 2015. AFTER THE JOINT REPLACEMENT, I NEEDED A COUPLE OF REVISION SURGERIES BECAUSE THE SCREWS LOOSENED AND MY JAW WAS OVER THE ONE SIDE. SHORTLY AFTER THE SURGERY, I BECAME UNABLE TO WORK. I DEVELOPED JOINT AND MUSCLE PAIN ALL OVER MY BODY. I STARTED SEEING HAIR LOSS ABOUT A YEAR OR TWO AFTER THE SURGERY. I THEN LOST ALL MY HAIR ON MY ENTIRE BODY. I WAS TOLD IT WAS AUTOIMMUNE ALOPECIA UNIVERSALIS. I HAD CONTACT DERMATITIS ON MY FACE, NECK, BACK AND CHEST. I HAD ECZEMA ON THE INCISION SITES AND OTHER PLACES ON MY BODY. I DEVELOPED SPLITTING PEELING FINGERNAILS. I WAS TOLD I HAD AN IMMUNE DEFICIENCY AT SOME POINT AFTER RECEIVING THE JOINTS. I HAD HASHIMOTO'S THYROIDITIS PRIOR TO THE IMPLANTS; HOWEVER, IT PROGRESSIVELY GOT WORSE AS MY DOSE OF SYNTHROID WENT FROM 88 MCG TO 175 MCG. MY PAIN WAS BAD REQUIRING OPIATE MEDICATIONS, BUT IT ALSO GOT WORSE OVER THE YEARS. I HAD PAIN IN THE AREA WHERE THE CONDYLE AND THE FOSSA WAS PLACED. I HAVE RECENTLY BEEN TOLD I HAVE DEVELOPED OSTEOARTHRITIS IN OTHER AREAS OF MY BODY. THIS YEAR I STARTED HAVING LOW GRADE FEVERS. MY OPENING DECREASED AND MY FUNCTION DECREASED. I DEVELOPED NUMBNESS ON MY FACE FOR NO APPARENT REASON AND I HAD INCREASED ELECTRIC SHOCK AND BURNING SENSATIONS. I ALSO DEVELOPED LOUD RINGING IN MY EARS, AND HEARING LOSS. I STARTED HAVING SYMPTOMS OF VERTIGO THAT I WAS TOLD IS PERMANENT. I ALSO DEVELOPED INCREASED ASTHMA SYMPTOMS WHICH REQUIRED 4 ASTHMA MEDICATIONS. PRIOR TO THE ASTHMA WORSENING I WAS ONLY USING A RESIDUE INHALER 1-2 TIMES PER MONTH. AFTER THE JOINTS WERE REMOVED, I STOPPED HAVING SEVERE PAIN IN MY JOINT AREA. MY ENERGY LEVEL HAS INCREASED. MY SYNTHROID DOSE HAS NOW DROPPED TO 112 MCG AND THE DOCTOR EVEN TOLD ME THAT I NO LONGER HAVE HASHIMOTO'S THYROIDITIS; I AM NO LONGER MAKING ANTI-THYROID ANTIBODIES. I ALSO HAD TO GET BRACES TO HOLD MY BITE AFTER THE SURGERY. I AM HAVING AN ALLERGIC WHICH DID NOT FORM UNTIL AFTER HAVING THE JOINTS. I FEEL LIKE I WAS SLOWLY BEING POISONED. I AM NOW LEFT IN A POSITION WHERE THERE ARE NO GOOD OPTIONS BECAUSE I AM ALLERGIC/SENSITIVE TO THE METALS. I AM HAVING SIGNIFICANT SLEEP APNEA PROBLEMS DUE TO MY LACK OF BONE IN MY JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480249 TMJ CONCEPTS TMJ IMPLANT TMJ CONCEPTS TMJ IMPLANT LZD TMJ SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S