BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 4101633 · Received August 27, 2014

    Report

    Report Number
    1822565-2014-01036
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    September 25, 2013
    Report Date
    July 29, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRUCIATE RETAINING FEMORAL COMPONENT IMPLANTED IS INCOMPATIBLE WITH THE POSTERIOR STABILIZED ARTICULAR SURFACE IMPLANTED. THE PACKAGE LABELING FOR THE FEMORAL COMPONENT INDICATES THAT THE COMPONENT IS A PRECOAT, CR-FLEX, SIZE E RIGHT. THE PACKAGE INSERT STATES "DO NOT USE: CR FLEX GSF FEMORAL COMPONENTS WITH NEXGEN LPS, LPS FLEX, OR PS ARTICULAR SURFACE COMPONENTS. THEY WERE NOT DESIGNED TO BE COMPATIBLE". DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT WERE REVIEWED AND FOUND CONFORMING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT. THE INITIAL SURGERY WAS UNEVENTFUL. THE NEXT DAY IT WAS REALIZED THAT A CRUCIATE RETAINING IMPLANT ON THE FEMORAL SIDE WAS UTILIZED RATHER THAN A POSTERIOR STABILIZED IMPLANT. AS A RESULT, A REVISION WAS DONE AND PATIENT SEEMED TO RECOVER NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522646 NEXGEN CR-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 62437674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention