BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON #5 PS INSERT 9MM

    MDR report key: 2251808 · Received August 31, 2011

    Report

    Report Number
    9610726-2011-00306
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DOCTOR LOCKED POLY AND FOUND IT WAS NOT SEATED. POSTERIOR LIP BROKE, PROCEEDED TO PLACE ANOTHER SAME SIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON #5 PS INSERT 9MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LCE332

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other