BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1473301 · Received September 14, 2009

    Report

    Report Number
    1644408-2009-00429
    Event Type
    Other
    Date Received
    September 14, 2009
    Date of Event
    August 10, 2009
    Report Date
    August 19, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER INTIAL REPORTER, ENCORE/(B) (4) SALES REPRESENTATIVE, SURGEONS NURSE WAS CONTACTED ON 08/19/2009 AND AGAIN ON 08/21/2009. BOTH TIMES THE NURSE STATED THAT NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS PT.

    Description of Event or Problem · 1

    REVISION SURGERY - BROKEN STEM ON PS TIBIAL INSERT. SZ. 6/13 ITBIAL POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM TIBIAL INSERT, PS HSH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention