BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT

    MDR report key: 2250864 · Received September 2, 2011

    Report

    Report Number
    2250864
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 2, 2011
    Manufacturer
    BIOMET, INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TO RETURN TO THE OR IN 2011 TO HAVE A TOTAL KNEE REVISION TO REMOVE FAILED UNICOMPARTMENTAL HARDWARE. THE UNICOMPARTMENTAL KNEE WAS PERFORMED IN 2007 SECONDARY TO MEDIAL COMPARTMENT ARTHRITIS. IT WAS NOTED IN NOVEMBER 2010 THAT XRAYS REVEALED LOOSENING OF THE RIGHT UNICOMPARTMENTAL COMPONENT. BY MAY 2011 THE PATIENT WAS EXPERIENCING ACHING SHARP PAIN AND PAIN AT REST OVER THE ANTERIOR ASPECT OF HER KNEE WITH OCCASIONAL NEED FOR PAIN MEDICATION. THE KNEE FELT UNSTABLE AND THE PATIENT HAD DIFFICULTY WITH STEPS. XRAYS: 4 VIEWS OF THE KNEE DEMONSTRATE COLLAPSE OF THE TIBIAL COMPONENT OF HER UNI KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT UNICOMPARTMENTAL TIBIAL TRAY HRY BIOMET, INC. 154719 1311521

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R