BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS FEM COMPONENT CEMENTED

    MDR report key: 2844976 · Received October 24, 2012

    Report

    Report Number
    2249697-2012-02012
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED WAS DISCARDED. SHOULD ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE OPERATING ROOM STAFF OPENED THE IMPLANT, THE INNER BLISTER WAS JAMMED IN AND PARTIALLY MELTED TOGETHER TO THE OUTER BLISTER. THIS EVENT HAPPENED DURING A RIGHT KNEE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS FEM COMPONENT CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA GZRA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other