BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXINIUM UNI

    MDR report key: 1012576 · Received March 12, 2008

    Report

    Report Number
    1020279-2008-00083
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 24, 2008
    Report Date
    March 6, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO BREAKAGE OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXINIUM UNI FEMORAL COMPONENT HSA SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. NA 03FM06985

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R PRODUCT NUMBER: 71248209, LOT NUMBER: 03ES0449| PRODUCT NUMBER: 725559, LOT NUMBER: 04AM08617| PRODUCT NUMBER: 727202, LOT NUMBER: 525557