BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS FEMORAL ANCHOR PLUG

    MDR report key: 1052038 · Received May 5, 2008

    Report

    Report Number
    1052038
    Event Type
    Malfunction
    Date Received
    May 5, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT FEMORAL RESECTION FOR TUMOR, WITH RECONSTRUCTION USING BIOMET TUMOR PROSTHESIS SYSTEM FEMORAL COMPONENT LATE LAST YEAR. THE PATIENT BEGAN TO NOTICE LEFT THIGH PAIN WITH NO INCIDENTAL TRAUMA, HE COULD FEEL HIS PROSTHESIS CLICKING. X-RAY REVEALED THAT THE PROSTHESIS HAD FRACTURED JUST DISTAL TO THE PROXIMAL FEMORAL PIN SITES. HE UNDERWENT A SECOND SURGERY 4 MONTHS LATER TO REMOVE THE BROKEN PROSTHESIS AND REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSS FEMORAL ANCHOR PLUG PROSTHESIS, KNEE JWH BIOMET, INC. 178404 054920

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR