BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT

    MDR report key: 952629 · Received November 21, 2007

    Report

    Report Number
    1822565-2007-00404
    Event Type
    Injury
    Date Received
    November 21, 2007
    Date of Event
    August 24, 2007
    Report Date
    October 24, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: LOOSENING OF THE HINGE POST EXTENSION CAN RESULT IF IT IS UNDER-TORQUED INITIALLY BECAUSE TIGHTENING OF THE HINGE POST EXTENSION TO THE RECOMMENDED TORQUE OF 130 IN. LB. IS CRITICAL FOR THE PROPER FUNCTIONING OF THE PARTS. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: ARTICULAR SURFACE EXHIBITS GOUGING DAMAGE TO THE CONDYLES AND DEFORMATION DAMAGE AROUND THE THRU HOLE ON THE BACKSIDE. THE HINGE POST EXTENSION EXHIBITS BURNISHING AND SCRATCHING FOR THE SHAFT AND THE THREAD HAVE MINOR DEFORMATION. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. DEVICE MEETS PRINT SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2006. APPROXIMATELY 1.5 YEARS POST-OP, THE LOCKING PIN AT THE ROTATING HINGE KNEE HAD LOOSENED. THE DEVICE WAS REVISED IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT KNEE PROSTHESIS HRZ ZIMMER, INC. NA 07880625

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R