BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP

    MDR report key: 2192674 · Received August 1, 2011

    Report

    Report Number
    MW5021605
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    May 29, 2008
    Report Date
    August 1, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE MY SURGERY, I HAVE GONE BACK TO THE DOCTOR SEVERAL TIMES COMPLAINING OF THE CHRONIC PAIN IN THE GROIN AREA, FEELING LIKE THE HIP WAS LOCKED OR CATCHING AND IF I MOVED IT JUST RIGHT, IT MIGHT POP OUT OF JOINT. DIFFICULTY WITH HIP FLEXION WHEN GOING UP AND DOWN STAIR AND WITH LIFTING MY RIGHT LEG, AND GETTING UP OUT OF A SITTING POSITION. I HAVE A HARD TIME SLEEPING AT NIGHT AND TRYING TO GET COMFORTABLE, NOT BEING ABLE TO SLEEP ON EITHER OF MY SIDES BECAUSE OF THE DISCOMFORT IN THE GROIN AREA. I EVEN SPENT THOUSANDS OF DOLLARS ON A BED HOPING IT WOULD HELP, ONLY TO STILL BE TRYING TO FIND THE COMFORT AND REALIZING IT'S NOT THE BED, IT'S THE HIP. AFTER THE DOCTOR TAKING X-RAYS I'M TOLD EVERYTHING LOOKS FINE, BUT IT IS OBVIOUS TO THE DOCTOR THAT I AM IN PAIN. I HAVE DONE PHYSICAL THERAPY OVER THE YEARS, INDOOR WATER EXERCISING, LOST WEIGHT, INJECTIONS IN GROIN AREA ONLY TO GET LITTLE OR TEMPORARY RELIEF OR NONE AT ALL. I AM SCHEDULED FOR A HIP REVISION ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACETABULAR CUP ACETABULAR CUP 100 KWA DEPUY B62ET1000
    2 DEPUY ARTICULEZE MOM FEMORAL HEAD 036MM, 12/14 CONE, +8.5 FEMORAL HEAD JDI DEPUY 2589482
    3 SUMMIT TAPERED HIP ST M W/DUOFIX HA 2 SZ, HI OFFSET, 130 MM HIP TAPER LWJ DEPUY
    4 PINNACLE METAL INSERT 36MM ID X 50MM OD NEUTRAL HIP INSERT LPH DEPUY

    Patients

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