BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT CLOSED BOX P/S CON KNEE FEMORAL

    MDR report key: 1003845 · Received February 8, 2008

    Report

    Report Number
    1825034-2008-00054
    Event Type
    Injury
    Date Received
    February 8, 2008
    Date of Event
    September 17, 2007
    Report Date
    January 16, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K993111
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMED WILL FORWARD A COPY TO FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY IN 2005. SUBSEQUENTLY, PT REPORTED TO SURGEON THAT "SOMETHING WAS LOOSE AND SHARP" IN HER LEFT KNEE. RADIOGRAPHS NOTED SHIFT IN FEMORAL COMPONENT. RECORDS INDICATE PT RETURNED FOR PARTIAL REVISION PROCEDURE IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENT CLOSED BOX P/S CON KNEE FEMORAL JWH JWH BIOMET, INC. NA 369870

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R