BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR FEM COMP #5 L-CEM

    MDR report key: 1915392 · Received November 17, 2010

    Report

    Report Number
    9610726-2010-00443
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT WHEN SHE OPENED THE OUTER PACKET (BOX) OF THE IMPLANT (B)(4) THE PART OF THE INNER PACKET (PAPER) HAD RIPPED OF (SIZE OF THE PAPER PIECE = 5CM) AT THE SAME TIME. THE INNER PACKET STAYED UNBROKEN. THE CUSTOMER MANAGED TO CONTINUE THE OPERATION USING ANOTHER TRIATHLON IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON CR FEM COMP #5 L-CEM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other