BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURATION PATELLA LRG

    MDR report key: 2032259 · Received March 23, 2011

    Report

    Report Number
    9610726-2011-00082
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSX
    PMA / PMN Number
    K872735
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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

    IT WAS REPORTED THAT, "PATIENT HAD A WORN PATELLA. REVISED AND REPLACED WITH A KINEMAX LARGE PATELLA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURATION PATELLA LRG IMPLANT HSX STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention