BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT

    MDR report key: 960780 · Received December 7, 2007

    Report

    Report Number
    1822565-2007-00422
    Event Type
    Injury
    Date Received
    December 7, 2007
    Date of Event
    November 7, 2007
    Report Date
    November 9, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POLY BOX SHOWS DEFORMATION DAMAGE TO THE BUMP STOP WHICH POSSIBLY ALLOWED THE KNEE TO GO INTO HYPEREXTENSION. X-RAYS ARE NOT AVAILABLE FOR REVIEW OF PLACEMENT AND ALIGNMENT OF IMPLANTS. THE CAUSE OF HYPEREXTENSION CANNOT BE DEFINITIVELY DETERMINED. ARTICULAR SURFACE EXHIBITS SIGNIFICANT GOUGING/PITTING ON CONDYLES AND ON INFERIOR SURFACE. HINGE POST EXTENSION IS SEIZED IN HINGE POST. POLY BOX INSERTS EXHIBITS DEFORMATION ON MULTIPLE SURFACES INCLUDING BUMP STOP. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. DEVICE MEETS PRINT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2005. REVISION SURGERY OCCURRED IN 2007, DUE TO HYPERTENSION.

    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 54939500

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R