BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IX FEMUR MESH PA MIDI 300 L

    MDR report key: 2162209 · Received July 7, 2011

    Report

    Report Number
    9610726-2011-00240
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K973121
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 CUSTOMER REPORTED THAT, "(B)(6) PT UNDERWENT A SURGICAL PROCEDURE OF TKR ON 2000. ON (B)(6) 2011 THE PT UNDERWENT AN UNANTICIPATED REVISION SURGERY DUE TO LOOSENING OF THE FEMORAL COMPONENT OF THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IX FEMUR MESH PA MIDI 300 L IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LJUCN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention