BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 10816822 · Received November 10, 2020

    Report

    Report Number
    0002249697-2020-02392
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    July 1, 2018
    Report Date
    November 10, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    THIS PI IS FOR REVISION OF PRIMARY. IT WAS REPORTED THROUGH A PATIENT¿S FORUM IN INTERNET, "MY LTHR WAS IN 2015. DID GREAT FOR 3 1/2 YEARS THEN HAD A FALL ON MY LEFT HIP. I GOT UP AND WENT ON WITH NO APPARENT INJURY. 3 DAYS LATER MY FIRST DISLOCATION. PAIN INCREDIBLE, AMBO RIDE TO NEAREST TRAUMA CENTER ER, REDUCTION UNDER ANESTHESIA, DISCHARGED TO BE SUPER CAREFUL AS 2ND DISLOCATION IS VERY POSSIBLE DUE TO DAMAGE TO MUSCLES, FOLLOW HIP PRECAUTIONS. 2 WEEKS LATER AGAIN IT HAPPENED AGAIN, SAME PROCESS ABOVE. ONE MONTH LATER 3RD TIME. MUSCLES ARE MUSH BY THIS TIME, CANT DO EXERCISES DUE TO TOTAL REVISION BEING SCHEDULED AND NEED TO JUST KEEP IT IN PLACE TIL SURGERY. REVISION DONE (B)(6) 2018 AND A NOW 3/4" LONGER LEFT LEG UGH. POST OP RECOVERY VERY SLOW BUT STEADY. PT IN SEP AND EXCEPT FOR LIMP WAS DOING GREAT UNTIL (B)(6) WHEN THE BRAND NEW BETTER IMPLANT (NOT) DISLOCATED. BACK TO SQUARE 1. AFTER THIS I SOUGHT A SECOND OPINION FROM HIGHLY RECOMMENDED ORTHO WHO WAS BLOWN AWAY BUT WARNED ME TO BE VERY CAREFUL IF IT DISLOCATED AGAIN HE WOULD TAKE IT ON AND TRY TO HELP ME. I WAS MORTIFIED AT THE POSSIBILITY OF STARTING OVER BUT HAD CONFIDENCE HE COULD. THEN IT HAPPENED AGAIN (YEP #5) . THIS TIME THOUGH IT WAS VERY HARD TO GET IT IN PLACE AND AFTERWARD I WAS IN EXCRUCIATING PAIN AND COULD BARELY WALK. THE 2ND REVISION WAS DONE (B)(6) 2019 AND IT WAS FOUND THAT THE IMPLANT USED LAST (B)(6) FAILED. PART OF IT WAS OUT OF THE SOCKET AND FLOATING OUTSIDE MY HIP AND THE ROOT CAUSE OF MY DEBILITATING PAIN. WITH MY USUAL BAD LUCK, I GOT AN INFECTION IN THE WOUND DOWN TO THE HIP AND HAD A 3RD REVISION 2 1/2 WEEKS LATER, 3-6 MONTHS OF ANTIBIOTIC. THE UPSIDE TO THE WHOLE ORDEAL IS 1 WEEK AFTER MY 3RD SURGERY IN 9 MONTHS I WAS AND AM STILL PAIN FREE. WEAK MUSCLES STILL BUT I WALK 1-2 MILES A DAY WITH A CANE, I'M (B)(6), LIVE ALONE AND HAVE 2 CATS TO CARE FOR. I AM CERTAIN I HAVE A PRODUCT LIABILITY CLAIM FOR THE STRYKER DUAL MOBILITY IMPLANT THAT FAILED. FOR NOW MY FOCUS IS ON RECOVERY. I'M 4 MONTHS OUT TOMORROW AND TAKE NO PAIN MEDS AT ALL, HAVE NO PAIN. I DO EXERCISES DAILY BUT MUSCLE MEMORY IS NOT KICKING IN YET. ENERGY IS NOT NORMAL YET BUT MY BODY HAS TAKEN A LOT THIS PAST 14 MONTHS. MY NEW SURGEON IS VERY HAPPY WITH MY PROGRESS AND HAS NEVER SEEN ANYTHING LIKE WHAT HAPPENED TO ME BEFORE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284256 UNKNOWN HIP PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R