BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER LFIT ANATOMIC HEAD

    MDR report key: 3246484 · Received July 8, 2013

    Report

    Report Number
    3246484
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DISLOCATED L THA, ACETABULAR COMPONENT FAILURE. PLAIN FILMS OBTAINED IN THE ED OF AP PELVIS AND HIP DEMONSTRATE A WELL-SEATED FEMORAL COMPONENT AND DISLOCATION OF THE ACETABULAR COMPONENT WITH SHEARING OF THE SCREWS WHICH WERE PREVIOUSLY HOLDING THAT COMPONENT TO THE ACETABULUM ITSELF. THERE ARE SOME AREAS OF LYSIS IN THE ILIUM WHERE THIS CUP WAS PREVIOUSLY SEATED. THERE IS PROXIMAL MIGRATION OF THE FEMORAL COMPONENT WHICH IS ESSENTIALLY DISLOCATED DUE TO THE LOSS OF THE ACETABULAR COMPONENT. THERE ARE ALSO POSTTRAUMATIC CHANGES AND CHRONIC CHANGES AROUND THE FEMORAL COMPONENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THA REVISION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310035 C-TAPER LFIT ANATOMIC HEAD PROSTHESIS, HIP, HEAD KWY STRYKER ORTHOPAEDICS UNK MJDTLY
    310036 * PROSTHESIS, HIP, LINER KWB STRYKER ORTHOPAEDICS UNK 60938390
    310037 * PROSTHESIS, HIP, SHELL JDI STRYKER ORTHOPAEDICS UNK 60878394

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR