BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THRIATHLON PS FEM COMP #8R-CEM

    MDR report key: 2192506 · Received June 30, 2011

    Report

    Report Number
    9610726-2011-00226
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 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
    NJ, 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, "THE INNER MOST PACKAGING OF THE IMPLANT WAS NOT SEALED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THRIATHLON PS FEM COMP #8R-CEM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SB8AX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR