BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH AND NEPHEW

    MDR report key: 2093894 · Received May 12, 2011

    Report

    Report Number
    MW5020600
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    March 28, 2010
    Report Date
    May 12, 2011
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A TOTAL RIGHT HIP REPLACEMENT (SMITH AND NEPHEW HIP) IN (B)(6) 2008. WHEN THE HIP WAS 14 MONTHS OLD - (B)(6) 2010, IT POPPED OUT 2 TIMES. THE ORTHOPEDIST HAD NO IDEA WHY. WE WENT ON A CRUISE RIGHT AFTER I WENT TO THE DR - LEFT (B)(6) 2009. WAS EXTREMELY CAREFUL WITH ALL ACTIVITIES. WE GOT OFF THE CRUISE IN (B)(6) AND ABOUT A HOUR LATER, I WAS JUST STANDING IN THE LOBBY OF A HOTEL, WAITING FOR MY HUSBAND. MY HIP POPPED OUT, I FELL AND GOT A CONCUSSION. I HAD TO HAVE A REVISION, AND REHAB THERE. I WAS OUT OF CT FOR OVER A MONTH. I CONTINUED REHAB AT HOME. I WAS OUT OF WORK FOR 4 MONTHS. I STILL WALK WITH A LIMP, HAVE A VERY WEAK QUADS MUSCLE, AND THE BACK IS MUCH WORSE, AND SOME OF THE NERVES ARE NOW DAMAGED. I HAVE NUMBNESS IN THE ENTIRE RIGHT LEG, AND SHARP STABBING PAINS ALL OVER THE RIGHT LEG, THAT COME AND GO. THIS SEEMS TO BE PERMANENT, AND DID NOT EXIST BEFORE THE HIP POPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH AND NEPHEW HIP BALL KWY SMITH AND NEPHEW
    2 SMITH AND NEPHEW CUP JDI SMITH AND NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R