BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC MODULAR HEAD

    MDR report key: 725579 · Received June 12, 2006

    Report

    Report Number
    1825034-2006-00057
    Event Type
    Injury
    Date Received
    June 12, 2006
    Date of Event
    May 18, 2006
    Report Date
    May 16, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    LZO
    Removal / Correction Number
    Z-225-2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THIS TYPE OF EVENT CAN OCCUR. THIS IS THE SECOND KNOWN REPORT ON ITEMS IDENTIFIED ON CORRECTION AND REMOVAL (Z-222/227-2). A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. THE FOLLOWING USER FACILITY INFORMATION IS AVAILABLE: KAREN EARLY, RISK MANAGMENT, 203-739-7000. THIS REPORT FILED ON JUNE 12, 2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON FEBRUARY 11, 2000. MODULAR HEAD COMPONENT FRACTURED AND REVISION PROCEDURE WAS PERFORMED ON MAY 18, 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMIC MODULAR HEAD PROSTHESIS, HIP, COMP. LZO BIOMET, INC. NA 854680

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R