BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #1

    MDR report key: 3781108 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01717
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE BECAUSE IT IS CURRENTLY IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAS EXPRESSED CONCERNS WITH ACCOLADE TMZF STEM IN REGARDS TO THE TRUNNION. HE HAS EXPERIENCED THE HEAD IMPINGING ON THE NECK OF THE STEM CAUSING TRUNNINOSIS. THE CASE INVOLVED A VERY LARGE HEAD SIZE ON THE STEM (40MM+) WHICH COULD LEAD TO THE HEAD IMPINGING ON THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259951 ACCOLADE TMZF HIP STEM #1 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other