BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE 4 9MM

    MDR report key: 2234027 · Received August 29, 2011

    Report

    Report Number
    9610726-2011-00301
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "POLY EXCHANGE FOR MID RANGE INSTABILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3 TRIATHLON CS INS SIZE 4 9MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LBJ559

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention