BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 724549 · Received June 9, 2006

    Report

    Report Number
    1822565-2006-00142
    Event Type
    Injury
    Date Received
    June 9, 2006
    Date of Event
    April 18, 2006
    Report Date
    May 12, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION F WAS COMPLETED BY THE MANUFACTURER. INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. H3: EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. H6: EVALUATION CODES: 100-68 CONGRUENT TIBIAL INSERT EXHIBITS WEAR ON MEDICAL AND LATERAL ARTICULATING SURFACES AND ON SPINE. SCANNING ELECTRON MICROSCOPY ANALYSIS SHOWED WEAR AND THIRD BODY PARTICLES. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE PARTICLES SHOWED C, O, AL, SI, MG, CA, S CL, K, NA, AND FE, AND ANALYSIS OF INSERT MATERIAL SHOWED A CARBON PEAK IN SPECTRUM TYPICAL OF UHMWPE. MANUFACTURING RECORDS COULD NOT BE REVIEWED DUE TO INSUFFICIENT INFORMATION (LOT NUMBER).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED ON JUNE 19, 2000. THE PT HAD CYSTIC LESIONS DEVELOPING IN THE PROXIMAL PORTION OF THE TIBIAL DISTAL TO THE TIBIAL BASEPLATE STEM. THE DEVICE WAS REVISED ON APRIL 18, 2006. DR. BUIE'S INTEROPERATIVE FINDINGS "FOUND THAT THERE WERE TRACTS EXTENDING DOWN INTO THE CYSTIC AREA FROM THE MEDIAL SCREW. THIS ALL WAS DEBRIDED AND WAS SENT TO PATHOLOGY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R