BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EIUS UNI KNEE LRG FEM RM/LL

    MDR report key: 1053362 · Received May 28, 2008

    Report

    Report Number
    9610726-2008-00021
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 19, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    992287
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "LOOSE FEMORAL COMPONENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIUS UNI KNEE LRG FEM RM/LL IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LUTPU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention