BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS/FINN SPINDLE

    MDR report key: 1191935 · Received October 9, 2008

    Report

    Report Number
    1825034-2008-00262
    Event Type
    Injury
    Date Received
    October 9, 2008
    Date of Event
    February 5, 2004
    Report Date
    September 12, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    KRO
    PMA / PMN Number
    K031804
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 ENROLLED IN CLINICAL STUDY UNDERWENT INITIAL SURGERY IN EARLY 2003. SUBSEQUENTLY, REVISION PROCEDURE WAS PERFORMED IN 2005, DUE TO DEEP PROSTHETIC INFECTION, SEVERE, TREATED WITH RESECTION OF IMPLANT AND INSERTION OF SPACER, IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESS/FINN SPINDLE PROSTHESIS, KNEE COMPONENT KRO BIOMET INC. N/A 181050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R