BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELEX MAGNUM

    MDR report key: 2933253 · Received December 31, 2012

    Report

    Report Number
    2933253
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BIOMET INC.
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PRESENTED TO E.D. WITH A CHIEF COMPLAINT OF LEFT HIP PAIN. PATIENT RECENTLY UNDERWENT A REVISION LEFT TOTAL HIP ARTHROPLASTY THAT WAS PERFORMED IN THE FALL OF LAST YEAR. THE PATIENT WAS LAST SEEN APPROXIMATELY TWO MONTHS AFTER THE REVISION FOR EVALUATION S/P EXACERBATION OF PAIN. FEMORAL STEM, FEMORAL HEAD, THREE POSTS, CEMENT CUP, AND ACETABULAR LINER REMOVED PER SURGICAL MDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELEX MAGNUM PROSTHESIS, FEMORAL HEAD LZO BIOMET INC. 910620 041340
    2 UNK PROSTHESIS, FEMORAL STEM LZO BIOMET INC. * *
    3 CEMENT CUP PROSTHESIS, HIP, CEMENT LOD ZIMMER INC. UNK UNK
    4 * PROSTHESIS, HIP, ACETABULAR KWB ZIMMER INC. * 62023704

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR