BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP IMPLANT

    MDR report key: 2093863 · Received May 16, 2011

    Report

    Report Number
    MW5020597
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    SMITH & NEPHEW
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD FIRST REVISION (B)(6) 2009 DUE TO TOXIC LEVELS OF METAL IN BLOOD AND REACTIONS TO METAL. PT EXPERIENCED INFLAMMATION AND TISSUE DAMAGE CAUSED IMPLANT TO DISLOCATE. PT WAS AGAIN REVISED (B)(6) 2011 FOR DISLOCATION AND AGAIN (B)(6) 2011. PT HAD TO WEAR A BRACE FOR DISLOCATION WHICH AFFECTED HER QUALITY OF LIFE. PT HAS HAD A TOTAL OF 3 SURGERIES AND 11 DISLOCATIONS SINCE ORIGINAL IMPLANT. THE LAST IMPLANT USED, IS A DIFFERENT MFR AND A LARGER HEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP IMPLANT SHELL JDI SMITH & NEPHEW 085M09728
    2 HIP IMPLANT LINER JDI SMITH & NEPHEW 08MW20484
    3 HIP IMPLANT HEAD KXA SMITH + NEPHEW 08DW16548
    4 HIP IMPLANT HEAD SLEEVE KXA SMITH & NEPHEW 08HW18177

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R