BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRON

    MDR report key: 2231827 · Received September 1, 2011

    Report

    Report Number
    1020279-2011-00347
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE SIGNES OF IMPINGEMENT WHICH MAY HAVE INCREASED THE AMOUNT OF LINER POLYETHYLENE WEAR (DUE TO ALTERED LOADING CONDITIONS) AND COULD ALSO HAVE CONTRIBUTED TO MECHANICAL LOOSENING. RELATIVE MOTION BETWEEN THE STEM AND FEMUR WOULD GENERATE THIRD BODY DEBRIS THAT COULD HAVE CONTRIBUTED TO THE ABRASIVE THIRD BODY WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRON FEMORAL COMPONENT JDH BROOKS MANUFACTURING SITE 406377

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R