BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY INC

    MDR report key: 386316 · Received April 1, 2002

    Report

    Report Number
    MW1024566
    Event Type
    Malfunction
    Date Received
    April 1, 2002
    Date of Event
    March 18, 2002
    Report Date
    March 28, 2002
    Manufacturer
    DEPUY INC
    Product Code
    GDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRAMEDULLARY FEMORAL GUIDE INSERTED FEMORAL CANAL DURING TOTAL KNEE REPLACEMENT PROCEDURE FEMORAL GUIDE TIP BROKE OFF IN CANAL APPROX 3 INCHES LEFT IN PT. UNABLE TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY INC INTRAMEDULLARY FEMORAL GUIDE GDF DEPUY INC H0399 96-6120 JJO 40CM

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other 1. SIZE 3PFC SIGMA POSTERIOR STABILIZED FEMORAL| 4. 25MM IN SET PATELLA.| COMPONENT.| 2. 3PFC SIGMA TIBIAL TRAY.| 3. 12.5MM POSTERIOR STABILIZED POLYETHYLENE| TIBIAL TRAY.