BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYL

    MDR report key: 759002 · Received September 8, 2006

    Report

    Report Number
    1822565-2006-00213
    Event Type
    Injury
    Date Received
    September 8, 2006
    Date of Event
    July 20, 2006
    Report Date
    August 8, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS LIKELY THAT THE SUPPORT SCREW WAS OVER TORQUED MORE THAN RECOMMENDED , CAUSING A FRACTURE AFTER A CERTAIN NUMBER OF CYCLES IN A SHORT PERIOD OF TIME. EVALUATION CODES: DEVICE WAS RETURNED WITH A FRACTURED SUPPORT SCREW. THIS FRACTURE OCCURRED APPROXIMATELY 3/8" FROM DISTAL END. FRACTURED COMPONENT WAS NOT RETURNED. DEVICE SHOWS WEAR ON BOTH CONDYLES AND DEFORMATION TO SIDE OF SPINE. SCANNING ELECTRON MICROSCOPE EXAMINATION SHOWED SHEAR DIMPLES. FRACTURE APPEARS TO HAVE OCCURRED BY OVERLOAD IN TORSION. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF SCREW MATERIAL SHOWED TI, AI AND V ELEMENTAL PEAKS IN SPECTRUM THAT ARE TYPICAL OF A TIVANIUM ALLOY. DEVICE HISTORY RECORDS ARE INTACT, CONFORMING AND INDICATING MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2006, AND REVISED POST-OP APPROXIMATELY 6 MONTHS LATER, DUE TO FRACTURE OF THE LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYL KNEE PROSTHESIS JWH ZIMMER, INC. NA 78172800

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R