BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT INSERT MED 12MM

    MDR report key: 4583240 · Received March 9, 2015

    Report

    Report Number
    0002249697-2015-00642
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K921640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT NO FURTHER INFORMATION OR DOCUMENTATION WILL BE PROVIDED FROM THE HOSPITAL OR SURGEON DUE TO POLICY. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT KNEE WAS BEING REVISED DUE TO PAIN. INTRAOPERATIVELY THE SURGEON NOTED POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162566 KX+ DURAT INSERT MED 12MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R