BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET ADAPTER 4MM

    MDR report key: 1053361 · Received May 28, 2008

    Report

    Report Number
    9610726-2008-00022
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 12, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    FJP
    PMA / PMN Number
    973164
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT CAME TO CLINIC FOR ANTERIOR THIGH PAIN. UPON X-RAY, IT WAS NOTED THAT COMPONENTS WERE DISSOCIATED AND THE THREADED PART OF THE OFFSET WAS SHEARED OFF AT THE BASE OF THE THREADS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFSET ADAPTER 4MM IMPLANT FJP STRYKER ORTHOPAEDICS LIMERICK NA LYA0010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention