BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ACETABULAR CUP PINNACLE SECTOR

    MDR report key: 1983621 · Received February 5, 2011

    Report

    Report Number
    MW5019311
    Event Type
    Injury
    Date Received
    February 5, 2011
    Report Date
    February 5, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2006, I STARTED HAVING SWELLING IN MY LEFT LEG. HAD X-RAYS FOR BLOOD CLOTS BUT NONE FOUND. THIS WAS RIGHT AFTER MY FIRST HIP REPLACEMENT. DR SAID HE HAD NO EXPLANTATION FOR IT. SO, FINALLY, IT WENT DOWN WITH ME KEEPING MY LEG PROPPED UP, BUT WHEN I QUIT KEEPING IT UP ALL THE TIME, IT WOULD SWELL BACK AGAIN. AFTER TWO YEARS OF THIS, MY OTHER HIP HAD TO BE REPLACED BECAUSE BONE AGAINST BONE. AFTER A FEW MONTHS, I STARTED HAVING PAIN IN MY RIGHT HIP. THE DOCTOR GAVE ME AN INJECTION OF 60 MG DEPO-MEDROL. ALL OF THIS TIME HE HAS NEVER SAID THE METAL HIP WAS ANY PROBLEM. THEY ARE METAL AGAINST METAL. I CAN'T SIT VERY LONG WITHOUT PAIN, CAN'T WALK VERY FAR WITHOUT PAIN IN MY HIPS AND LEGS HURTS. I STILL HAVE SOME LEG SWELLING ALSO. I DON'T PICK UP TOO MUCH HEAVY THINGS. BUT WHERE IS MY MORE HEALTHIER LIFE FOR CHANGING MY LIFE. DON'T HAVE ANY STRENGTH TO PLAY WITH MY GRAND KIDS OR EVEN A LIFE WITH MY HUSBAND. THANK GOD FOR HIM, HE DOES ALL THE THINGS I'M SUPPOSED TO DO AS A WIFE, MOTHER, AND GRANDMOTHER. WHERE IS MY LIFE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ACETABULAR CUP PINNACLE SECTOR DEPUY ORTHOPAEDICS KWA DEPUY ORTHOPAEDICS AJ5FF1000
    2 DEPUY HOLE ELIMINATOR-PS DEPUY OTHOPAEDICS LXH DEPUY ORTHOPAEDICS AH6EJ1000
    3 DEPUY PINNALCE O METAL INSERT DEPUY ORTHOPAEDICS KWA DEPUY ORTHOPAEDICS
    4 DEPUY S-ROM M METAL ON METAL FEMORAL DEPUY ORTHOPAEDICS FSM DEPUY ORTHPAEDICS
    5 DEPUY PINNACLE BONE SCREW DEPUY ORTHOPAEDICS HWC DEPUY ORTHOPAEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention