BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS EXTENSION PIECE 80MM

    MDR report key: 1071399 · Received July 3, 2008

    Report

    Report Number
    9610726-2008-00038
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    April 9, 2008
    Report Date
    June 12, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PT UNDERWENT A REVISION SURGERY DUE TO THE LOOSENING OF THE INNER CONE IN THE ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMRS EXTENSION PIECE 80MM IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA LXBDS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention