BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED (LPS) ARTICULAR

    MDR report key: 874212 · Received June 29, 2007

    Report

    Report Number
    1822565-2007-00209
    Event Type
    Injury
    Date Received
    June 29, 2007
    Date of Event
    January 25, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CAUSE CANNOT BE DETERMINED; HOWEVER, PRESENCE OF 3RD BODY PARTICLES CONTRIBUTED TO WEAR OF POLY. DEVICE EXHIBITS WEAR AND PITTING TO BOTH CONDYLES. THERE ARE VISIBLE FOREIGN PARTICLES EMBEDDED ON ONE CONDYLE. SCANNING ELECTRON MICROSCOPE EXAMINATION SHOWED EXTENSIVE WEAR AND PITTING. PARTICLES SHOWING CO, CR, AND AL, SI, K WERE OBSERVED ON ARTICULATING SURFACE. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF MATERIAL SHOWED A CARBON PEAK IN SPECTRUM TYPICAL OF UHMWPE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2004 AND REVISED IN 2007, DUE TO PAIN AND LOOSENING OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED (LPS) ARTICULAR KNEE PROSTHESIS JWH ZIMMER, INC. NA 53145500

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R