BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT

    MDR report key: 1980176 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00164
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ABSENCE OF PMMA COATING REMAINING ON THE TIBIAL COMPONENT WOULD INDICATE THAT THE BONE CEMENT WAS PUT ON THE TIBIAL COMPONENT IN THE CORRECT STAGE OF POLYMERIZATION TO ACTIVATE THE PMMA PRECOAT. IT IS UNKNOWN, HOWEVER, AT WHAT STAGE IN THE POLYMERIZATION PROCESS THE IMPLANT WAS PLACED INTO THE PATIENT. THE LARGE AMOUNT OF PITTING ON BOTH SIDES OF THE ARTICULAR SURFACE COULD INDICATE THE PRESENCE OF THIRD BODY PARTICLES, SUCH AS RESIDUAL BONE CEMENT, IN THE JOINT. THESE OBSERVATIONS WERE TAKEN INTO CONSIDERATION; HOWEVER, WITHOUT ADDITIONAL INFORMATION, THE CAUSE OF LOOSENING COULD NOT BE DETERMINED. EVALUATION: AS RETURNED, THERE IS NO BONE CEMENT ADHERED TO THE INFERIOR SURFACE OF THE TIBIAL PLATE. IT WAS OBSERVED THAT THE TIBIAL PLATE HAS SOME CIRCULAR SCRATCHES ON THE PROXIMAL SURFACE WHICH COULD BE ATTRIBUTED TO THE ARTICULATION OF THE ARTICULAR SURFACE. THERE APPEARS TO BE A FAIRLY SIGNIFICANT AMOUNT OF PITTING AND STRIATIONS ON THE PROXIMAL AND DISTAL SURFACES OF THE ARTICULAR SURFACE. THE SCRATCHES ON THE DISTAL SURFACE ARE IN A CIRCULAR PATTERN AND COULD BE ATTRIBUTED TO ARTICULATION WITH THE TIBIAL PLATE. MANUFACTURING DOCUMENTATION FOR THE REPORTED LOTS HAS BEEN REVIEWED AND INDICATES THE DEVICES WERE MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT JWH ZIMMER, INC. 61034679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention