BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CEMENTED PS FEMORAL COMPONENT #8 RIGHT

    MDR report key: 2000027 · Received February 3, 2011

    Report

    Report Number
    9610726-2011-00027
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "OPEN #8RT PS FEMORAL COMPONENT BOX, STAFF FOUND THE OUTER BLISTER BROKEN. THEY OPENED A BACKUP IMPLANT SAME CATALOG NUMBER WITH NO ADVERSE CONSEQUENCE TO PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON CEMENTED PS FEMORAL COMPONENT #8 RIGHT INSTRUMENT JWH STRYKER ORTHOPAEDICS LIMERICK NA SCPEN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other