BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD

    MDR report key: 1160287 · Received September 16, 2008

    Report

    Report Number
    1825034-2008-00229
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    January 22, 2007
    Report Date
    August 18, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    KWY
    PMA / PMN Number
    K003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. THIS REPORT FILE SEPTEMBER 16, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN 2002. PATIENT DISLOCATED AND RETURNED TO SURGERY IN EARLY 2007 FOR REVISION PROCEDURE. LINER, SHELL, MODULAR HEAD AND SCREW COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MODULAR HEAD PROSTHESIS, HIP COMPONENT KWY BIOMET INC. N/A 816180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R