BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN RHK FEMORAL COMPONENT

    MDR report key: 5124218 · Received October 2, 2015

    Report

    Report Number
    1822565-2015-02068
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 3, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED:CATALOG # 00588005014, RHK ARTICULAR SURFACE, LOT # 62257949REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT AND ARTICULAR SURFACE IDENTIFIED NO DEVIATIONS OR ANOMALIES. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATIONS OF THE FEMORAL COMPONENT OR ARTICULAR SURFACE. OPERATIVE NOTES FROM THE PRIMARY SURGERY WERE NOT RETURNED. OPERATIVE NOTES FROM THE REVISION SURGERY INDICATE THE PATIENT HAD EXPERIENCED A DISLOCATION OF THE KNEE. THE NOTES INDICATE THE HINGE POST EXTENSION HAD LOOSENED FROM THE HINGE POST AND THE THREADS WERE EXPOSED. DURING THE SURGERY, THE FEMORAL COMPONENT WAS ALSO NOTED TO BE LOOSE AND WAS REVISED. THE TIBIAL COMPONENT WAS NOTED TO BE FIRMLY ANCHORED IN THE BONE. RETURNED X-RAYS CONFIRM THAT THE HINGE PIN EXTENSION HAD LOOSENED FROM THE HINGE POST AND HAD DISLOCATED. THE RHK SURGICAL TECHNIQUE STATES THAT THE HINGE POST EXTENSION SHOULD BE TORQUED TO 130 IN-LBS AND WARNS THAT UNDERTIGHTENING OF THE HINGE POST EXTENSION MAY ALLOW IT TO LOOSEN OVER TIME. PER THE RHK PACKAGE INSERT, BECAUSE THE ROTATING HINGE KNEE IS A HIGHLY CONSTRAINED DEVICE, THE RISK OF COMPONENT BREAKAGE, LOOSENING AND POLYETHYLENE WEAR MAY BE GREATER THAN FOR LESS CONSTRAINED KNEE IMPLANTS.A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AND DISASSEMBLY OF THE HINGE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652839 NEXGEN RHK FEMORAL COMPONENT KRO KRO ZIMMER INC 62080613

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention