BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 752663 · Received August 18, 2006

    Report

    Report Number
    1822565-2006-00189
    Event Type
    Injury
    Date Received
    August 18, 2006
    Date of Event
    April 4, 2006
    Report Date
    July 18, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ARTICULAR SURFACE OF INSERT LOOKS GOOD. ETCHING ON INFERIOR SIDE IS WORN OFF. AT THIS TIME, A DEFINITIVE CAUSE CANNOT BE DETERMINED. EVALUAITON: INSERT EXHIBITS MINIMAL PITTING TO ARTICULATING SURFACES AND STRIATIONS ON BACKSIDE. SCANNING ELECTRON MICROSCOPE EXAMINATION SHOWS WORN SURFACE WAS IN POLISHED CONDITION WITH FEW SCRATCHES, THIRD BODY PARTICLES AND RARE CAVITIES DUE TO MATERIAL REMOVAL. THIRD BODY PARTICLES WERE AL, SI, MG, CA, K, CI AND S. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS SHOWED A C (CARBON) PEAK IN THE SPECTRUM THAT IS TYPICAL OF A UHMWPE. DEVICE HISTORY RECORDS ARE INTACT, CONFORMING AND INDICATE MANUFACTURE TO SECIFICAITON.

    Description of Event or Problem · 1

    IT IS REPORTED THE DEVICE WAS IMPLANTED IN 1997. IN 2006, DURING A FOLLOW-UP VISIT, THE SURGEON NOTED ON X-RAY THAT OSTEOLYTIC LESIONS OR CYSTS HAD FORMED AROUND THE THREADS AND TIPS OF SCREWS USED TO AFFIX THE PLATE. THE PLATE ITSELF WAS NOT LOOSE. THE DEVICE WAS REVISED TWO MONTHS LATER.

    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 1271787

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R