BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRUAL-KNEE II SYSTEM ULTRA CONGRUENT TIBIAL INSERT

    MDR report key: 963836 · Received December 12, 2007

    Report

    Report Number
    1822565-2007-00425
    Event Type
    Injury
    Date Received
    December 12, 2007
    Date of Event
    October 15, 2007
    Report Date
    November 8, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: POLY SHOWS BACKSIDE WEAR AND COLD FLOW CONSISTENT WITH 6 YEARS AND 3 MONTHS IMPLANTATION. WEAR PERFORMANCE OF A COMPONENT IS DEPENDENT ON MANY FACTORS, INCLUDING PATIENT ACTIVITY AND PATIENT WEIGHT, MANY OF WHICH ARE OUT OF THE CONTROL OF THE MANUFACTURER. THE PROBABLE CAUSE OF FAILURE IS WEAR. H6: EVAL: BOTH ARTICULAR SURFACE COMPARTMENTS EXHIBIT WEAR AND DEFORMATION. A PORTION OF THE LATERAL POSTERIOR EDGE APPEARS TO HAVE BEEN WORN AWAY. THERE IS ALSO DEFORMATION TO THE MEDIAL ANTERIOR EDGE. THE BACKSIDE WAS THE ENGRAVINGS WORN AWAY. THERE ARE ALSO TWO OBLONG PROTRUSIONS ON THE BACKSIDE THAT CORRESPOND WITH THE HOLES IN THE BASEPLATE. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY ANALYSIS SHOWS WEAR DAMAGE ON ARTICULATING SURFACE AND THE BACKSIDE SURFACE. MACHINING MARKS WERE SEEN WORN OFF ON BOTH THE SURFACES. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE INSERT MATERIAL SHOWED A CARBON (C) PEAK IN THE SPECTRUM THAT IS TYPICAL OF UHMWPE. FEW PARTICLES SHOWING C AND O ELEMENTAL PEAKS AND SI, AL, MG, CA, K AND FE PEAKS WERE ALSO OBSERVED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2001. REVISION SURGERY OCCURRED IN 2007, DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATRUAL-KNEE II SYSTEM ULTRA CONGRUENT TIBIAL INSERT KNEE PROSTHESIS HSH ZIMMER, INC. NA 1457936

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R