BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEMMED TIBIAL COMPONENT

    MDR report key: 2113448 · Received May 31, 2011

    Report

    Report Number
    1822565-2011-01286
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: WITHOUT ADDITIONAL INFO, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS AND ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WERE PERFORMED. SEM ANALYSIS SHOWS THIRD BODY PARTICLES ON THE CONDYLES. EDS ANALYSIS SHOWS THESE PARTICLES HAVE THE CHEMICAL MAKEUP INDICATIVE OF BONE CEMENT. VISUAL INSPECTION OF THE TIBIAL PLATE SHOWS SCRATCHING ON THE SUPERIOR SURFACE WHICH INDICATES THE PRESENCE OF THIRD BODY PARTICLES. THERE IS SCRATCHING ON THE DISTAL/LATERAL PORTION AND THE PROXIMAL/MEDIAL PORTIONS OF THE TIBIAL STEM. THERE IS NO BONE CEMENT PRESENT. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S KNEE WAS REVISED FOR LOOSENING. EXCESSIVE WEAR WAS NOTED ON THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FLUTED STEMMED TIBIAL COMPONENT JWH ZIMMER INC 60840784

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN LPS ARTICULAR SURFACE: CATALOG# 00599604010| LOT# 60877957