BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS BONE CEMENT

    MDR report key: 1202333 · Received October 21, 2008

    Report

    Report Number
    1825034-2008-00272
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    August 9, 2007
    Report Date
    September 23, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    LOD
    PMA / PMN Number
    P810020
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE PROCEDURE IN 2005. SUBSEQUENTLY, PATIENT HAS UNDERGONE TWO (2) ARTHROSCOPIC PROCEDURES IN 2007, AND ABOUT THREE MONTHS LATER TO REMOVE BONE CEMENT FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS BONE CEMENT BONE CEMENT LOD BIOMET INC. N/A 003728

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R