BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5060771

    MDR report key: 5486159 · Received March 3, 2016

    Report

    Report Number
    MW5060771
    Event Type
    Injury
    Date Received
    March 3, 2016
    Report Date
    March 3, 2016
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD VITEK PROPLAST TEFLON IMPLANTED IN APPROX. 1984. SHE WAS ALWAYS SICK WITH FLU LIKE SYMPTOMS AND HAD A GREAT AMOUNT OF PAIN IN THE JOINT AREA. THE DEVICE WAS REMOVED IN 1990 AFTER SHE FOUND OUT ABOUT THE FDA RECALL - IT WAS IN FRAGMENTS. SHORTLY AFTERWARDS, SHE HAD A CHRISTENSEN ALL METAL WITH POLY HEAD IMPLANTED. A YEAR LATER THE PATIENT BEGAN EXPERIENCING PROBLEMS WITH THIS DEVICE, INCLUDING A LOT OF PAIN. THE PATIENT BECAME TOTALLY DISABLED AFTER THIS AND HAS NOT BEEN ABLE TO WORK SINCE 1993. THE CHRISTENSEN DEVICE WAS REMOVED AND TMJ CONCEPTS TOTAL JOINT WAS IMPLANTED IN 1998. ALSO, AT THE TIME OF THE SURGERY, IT WAS NOTED THAT THE AREA AT THE TOP OF THE BONE JUST ABOVE THE TOTAL JOINT, HAD A "MOTH EATEN" APPEARANCE SO THERE WAS A FEAR THAT PERHAPS A GIANT CELL REACTION HAD TRIED TO MIGRATE INTO HER BRAIN. FOLLOWING THE CONCEPTS DEVICE IMPLANTATION PROCEDURE, THE PATIENT'S SURGEON TESTED HER FOR METAL ALLERGIES AND SHE HAD A HORRIFIC REACTION DURING THE TEST. THE PATIENT GOES TO A PAIN MANAGEMENT DOCTOR FOR REGULAR BLOCKS INCLUDING STELLATE GANGLION BLOCKS. SHE WAS TOLD HER T-CELLS WERE SO LOW THAT IT LOOKED LIKE SHE HAD AIDS WHICH REQUIRED HER TO HAVE TESTS FOR THAT WHICH WERE NEGATIVE, BUT SHOWED THAT HER IMMUNE SYSTEM HAD BEEN SO COMPROMISED THAT SHE NEEDED 2 IVIG GAMMA GLOBULIN INFUSIONS. IN 2006, WHILE HAVING A BREAST MRI, HER DOCTORS FOUND A LARGE MEDIASTINAL MASS THAT WAS BETWEEN HER HEART AND LUNGS AND HAD TO BE REMOVED BY A THORACIC CARDIOLOGIST. SHE WAS ORIGINALLY DIAGNOSED WITH LYMPHOMA (MOST LIKELY NON-HODGKINS) BUT AFTER A SECOND OPINION OF THE BIOPSY IT WAS BENIGN AND SIMPLY CALLED A "DISEASE PROCESS" MEANING THEY HAD NO IDEA WHAT CAUSED IT. SHE WANTED TO SEE A DOCTOR FOR FOLLOW-UP ON PROBLEMS SHE HAS WITH BREAST HYPERPLASIA, BUT WAS UNABLE TO DO SO BECAUSE NO ONE WOULD TAKE HER (B)(6). PATIENT HAS A WHITE MASS ON HER BRAIN IN THE AREA THAT SOMEONE WITH MS WOULD HAVE, BUT THE MASS DOES NOT HAVE THE MARKINGS OF MS. PATIENT HAS NOT HAD A BRAIN SCAN DONE SINCE 2006. SHE'S DEVELOPING ALL KINDS OF SMALL LUMPS ON HER BACK WHICH NO ONE KNOWS WHAT THEY ARE. PATIENT HAS LOST QUITE A BIT OF WEIGHT SINCE THERE ARE ONLY A FEW THINGS SHE CAN CHEW WITHOUT PAIN AND NOW IT (AT TIMES) HURTS TO DRINK. PATIENT IS AFRAID OF HAVING SURGERY AGAIN AS THE CHANCE OF PERMANENT PARALYSES IS SO HIGH SINCE THERE ISA PROBABLY A GREAT DEAL OF HETEROTOPIC BONE FORMATION AGAIN AND BECAUSE OF THE PARALYSES THAT HAPPENED BEFORE. THE PATIENT IS EXPERIENCING A LOT OF PAIN AND ITCHINESS ALL OVER HER BODY AND IS ESPECIALLY SENSITIVE TO BEING OUT IN THE SUN. THE PATIENT HAS NOWHERE TO GO FOR TREATMENT AND DOES NOT HAVE A DOCTOR MONITORING HER CURRENT MEDICAL DEVICE. THE PATIENT SAID SHE RECENTLY FELT SOMETHING EXPLODE IN HER FACE. LAST CT SCAN WAS ABOUT 2 YEARS AGO. PATIENT HAS DEVELOPED SHORT-TERM MEMORY LOSS; VERTIGO; RINGING IN THE EARS; FATIGUE; DEPRESSION AND THE LIST GOES ON. THE PATIENT STATED THAT THIS IS A NEVER ENDING NIGHTMARE WHICH HAS STOLEN HER LIFE.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization| O| R| S