BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER CIRCONIA CERAMIC FEMORAL HEAD

    MDR report key: 625439 · Received August 8, 2005

    Report

    Report Number
    1822565-2005-00162
    Event Type
    Injury
    Date Received
    August 8, 2005
    Date of Event
    July 4, 2005
    Report Date
    July 14, 2005
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Removal / Correction Number
    1822565-08/16/2001-02R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED IN 3/1999. IN 2005, PT WENT TO EMERGENCY ROOM WITH HIP PAIN AND X-RAY REVEALED CERAMIC HEAD HAD FRACTURED. DEVICE WAS REVISED THE FOLLOWING DAY. SURGEON STATED THAT THE PT WAS NONCOMPLAINT, VERY ACTIVE, AND HAD BEEN PLAYING TACKLE FOOTBALL IN THE PREVIOUS WEEKS WHERE THEY WERE TACKLED AND ALSO TACKLED OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER CIRCONIA CERAMIC FEMORAL HEAD HIP PROSTHESIS LZO ZIMMER, INC. NA 56910100

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R