BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LFIT MORSE TAPER HEAD

    MDR report key: 4553870 · Received February 27, 2015

    Report

    Report Number
    0002249697-2015-00500
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 16, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STRYKER LFIT MORSE TAPER HEAD WAS MATED WITH A ZIMMER LINER. AS STATED IN THE IFU SUPPLIED WITH THE DEVICE "HOWMEDICA OSTEONICS CORP. STRONGLY ADVISES AGAINST THE USE OF ANOTHER MANUFACTURER¿S TAPERED FEMORAL STEM OR ACETABULAR COMPONENT WITH ANY HOWMEDICA OSTEONICS FEMORAL BEARING HEAD COMPONENT. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT." THEREFORE, THE USE OF A ZIMMER LINER WITH THE STRYKER HEAD IS NOT SANCTIONED BY STRYKER AND AS SUCH IS CONSIDERED AN OFF LABEL APPLICATION OF THE DEVICE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TRIDENT MULTI HOLE ACETABULAR SHELL. THE SURGEON MENTIONED THIS BEING THE PATIENT'S 2ND OR 3RD REVISION ON THE SAME HIP. IT CANNOT BE CONFIRMED IF PREVIOUS REVISIONS WERE OF STRYKER DEVICES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DISCARDED.

    Description of Event or Problem · 1

    THE ACETABULAR COMPONENT WAS LOOSE AND MIGRATED AS SEEN IN THE X-RAY FILM REQUIRING REVISION OF CUP, LINER, AND FEMORAL HEAD. THE CUP AND LINER WERE REPLACED WITH DEPUY IMPLANTS AND FEMORAL HEAD WAS REPLACED BY A MORSE TAPER/C-TAPER ADAPTER SLEEVE TO ACCOMMODATE A CERAMIC HEAD WITH +7.5MM OFFSET.

    Description of Event or Problem · 1

    THE ACETABULAR COMPONENT WAS LOOSE AND MIGRATED AS SEEN IN THE X-RAY FILM REQUIRING REVISION OF CUP, LINER, AND FEMORAL HEAD. THE CUP AND LINER WERE REPLACED WITH DEPUY IMPLANTS AND FEMORAL HEAD WAS REPLACED BY A MORSE TAPER/C-TAPER ADAPTER SLEEVE TO ACCOMMODATE A CERAMIC HEAD WITH +7.5MM OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138313 LFIT MORSE TAPER HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 57419701

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention