BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 3921625 · Received May 29, 2014

    Report

    Report Number
    3007963827-2014-00018
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 3, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE RETURNED OPERATIVE NOTES COULD NOT BE PERFORMED AS THE NOTES ARE HANDWRITTEN AND ILLEGIBLE. REVIEW OF THE RETURNED RADIOGRAPHS CONFIRMS NO CEMENT MANTLE AROUND THE FEMORAL OR TIBIAL COMPONENTS. THE TIBIAL COMPONENT IS A POROUS TRABECULAR METAL MONOBLOCK TIBIA AND CAN BE IMPLANTED WITHOUT THE USE OF CEMENT. A GAP IS VISUALIZED ON THE LATERAL RADIOGRAPH BETWEEN THE ANTERIOR CHAMBER CUT OF THE FEMUR AND THE FEMORAL COMPONENT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE FEMORAL COMPONENT IS A PMMA PRECOUT AND IS DESIGNED FOR CEMENTED USE ONLY. THE INSTRUCTIONS FOR USE STATE THAT THE COMPONENT IS INTENDED FOR CEMENTED USE ONLY. THE PACKAGING LABEL ON THE CARTON ALSO INDICATES THAT THE COMPONENT IS FOR CEMENTED USE ONLY. THE REPORTED ISSUE IS THEREFORE DUE TO FAILURE TO FOLLOW INSTRUCTIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON DID NOT USE THE CORRECT TECHNIQUE. THERE WAS NO CEMENT USED FOR THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316252 NEXGEN CR-FLEX GSF FEMORAL COMPONENT JWH ZIMMER 62401910

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR