BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #4

    MDR report key: 1842818 · Received September 15, 2010

    Report

    Report Number
    9616680-2010-00570
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 26, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE FROM THE RESEARCH FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE ARTHROPLASTY WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENTS AND THE ACETABULAR LINER WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 1.8Y. THE PATIENT PRESENTED WITH A (B)(6) SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND MAXIMUM SCORE OF 4."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 24328004

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention