BEUDAMED
    FDA Adverse Event Other Summary report: N

    MATTA PELVIC SYSTEM

    MDR report key: 4163200 · Received October 9, 2014

    Report

    Report Number
    MW5038543
    Event Type
    Other
    Date Received
    October 9, 2014
    Date of Event
    January 1, 1991
    Report Date
    October 9, 2014
    Product Code
    HRS
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES HE FRACTURED HIS LEFT AND RIGHT HIP IN 1991 AND SURGEON IMPLANTED THE MATTA PELVIC SYSTEM WITH THE INTENT TO REMOVE THE DEVICE AFTER 4 YEARS. CALLER STATES THAT SINCE THEN HE HAS UNDERGONE 9 SURGERIES DUE TO HIS LEGS GIVING OUT AND CAUSING HIM TO FALL. MOST RECENTLY THE CALLER STATES HE FELL IN (B)(6) 2014 DOWN A FLIGHT OF STAIRS. CALLER WAS TAKEN TO THE HOSPITAL AND EXPERIENCED SPINAL NERVE DAMAGE. SINCE THE DEVICE WAS IMPLANTED CALLER STATES HE HAS EXPERIENCED A BURNING SENSATION IN HIS FEET, NUMBING BETWEEN HIS LEGS, SWELLING IN HIS KNEES, BACK PAIN, AND LOSS OF SEX DRIVE. THE CALLER SUSPECTS HE HAS METAL TOXICITY AND WOULD LIKE THE DEVICE REMOVED BUT DUE TO INSURANCE CONSTRAINTS HAS NOT BEEN ABLE TO REMOVE IT. CALLER HAS ALREADY FILED A CLAIM FOR THE MANUFACTURER, HIS CLAIM NUMBER IS (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 11/24/2014: DEAR FDA, MY NAME IS (B)(6) AND I REPORTED TO FDA ABOUT THESE METAL PLATES THAT ATTACH TO MY PELVIS. MY NERVE IS DAMAGED FROM THESE METAL PLATES. MY SEX DRIVE IS GONE. I AM IN A LOT OF PAIN, MY LEFT SIDE WENT DEAD AND I FELL DOWN SOME STAIRS. MY LEFT ELBOW WAS BUSTED OPEN SO BAD (I TOOK PICTURE). I HURT IN MY GROIN, AND I AM GOING THROUGH THE SAME THING WHAT OTHER PATIENT IS GOING THROUGH. I'VE BEEN SUFFERING FOR MANY YEARS WITH THESE METAL PLATES. STRYKER SENT ME SOME PAPER WORK TO FILL OUT TO GET MY MEDICAL FILE. LORD KNOWS THE PAIN IS UNBEARABLE. SEE STRYKER DON'T CARE BECAUSE IF THEY DID, THEY WOULD TRY TO HELP THOSE THAT HAVE METAL DEVICES IN THEIR HIPS GET BETTER. I CAN'T RIDE IN CAR GOING A LONG RIDE BECAUSE MY HIP GOES NUMB. I AM PRAYING FOR JUSTICE. I PRAY THAT YOU ALL WILL MAKE STRYKER AND JOHNSON AND JOHNSON TAKE ALL METAL DEVICES OFF THE MARKET. I WAS TOLD STRYKER WOULD REIMBURSE ME FOR MONEY I SPENT ON MY MEDICINE, BUT MRS. (B)(6) SAID I GOT TO PAY FOR MY MEDICINE. WILL THE FDA HELP ME PLEASE, BECAUSE I KNOW STRYKER WILL NOT DO RIGHT BY ME. (B)(6). THANK YOU. THE TYPE OF METAL DEVICE IN BOTH PELVIS IS A MATTA PELVIC SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636921 MATTA PELVIC SYSTEM HIP IMPLANT HRS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR