BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZ

    MDR report key: 728598 · Received June 22, 2006

    Report

    Report Number
    1822565-2006-00136
    Event Type
    Injury
    Date Received
    June 22, 2006
    Date of Event
    May 16, 2006
    Report Date
    May 16, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3: EVALUATION SUMMARY: SEVERE DAMAGE TO SPINE APPEARS TO INDICATE CONTACT WITH FEMORAL COMPONENT PROBABLY DUE TO INSTABILITY CAUSED BY EXCESSIVE WEAR ON MEDICAL ARTICULATING SURFACE. SPINE MOST LIKELY FRACTURED DUE TO ABNORMAL ANTERIOR POSTERIOR ARTICULATION ON MEDIAL LATERAL ROTATION OF FEMORAL COMPONENT AND FATIGUE. H6: EVALUATION CODES: ARTICULAR SURFACE EXIHIBITS FRACTURE DAMAGE OF SPINE WITH DEFORMATION TO MEDICAL BEARING SURFACE AND DAMAGE TO SUPERIOR SURFACE ON POSTERIOR AND MEDIAL SIDES OF MEDIAL BEARING SURFACE. ACANNING ELECTRON MICROSCOPE EXAMINATION SHOWED STRIATIONS INDICATING FRACTURE OBSERVED BY FATIGUE. THIRD BODY WEAR PARTICLES WERE OBSERVED. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF INSERT MATERAIL SHOWED A CARBON (C) PEAK IN SPECTRUM TYPICAL OF UHMWPE. DEVICE HISTORY RECORDS ARE INTACT, CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2000. THE SPINE OF THE SURFACE BROKE OFF AND THE DEVICE WAS REVISED ON 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZ KNEE PROSTHESIS JWH ZIMMER, INC. NA 51278100

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R