BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR

    MDR report key: 739408 · Received July 21, 2006

    Report

    Report Number
    1822565-2006-00166
    Event Type
    Injury
    Date Received
    July 21, 2006
    Date of Event
    June 5, 2006
    Report Date
    June 20, 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: PRE-OP X-RAY SHOWS DISLOCATION OF FEMORAL & HINGE POST EXTENSION FROM TIBIAL AND TIBIA APPEARS ROTATED. LOCATION OF PATELLA TO FEMORAL INDICATES LAXITY OF PATELLA TENDON WHICH MAY HAVE RESULTED IN JOINT INSTABILITY & SUBSEQUENT DISLOCATION OF FEMORAL ASSEMBLY. JOINT INSTABILITY CAUSED DUE TO LAXITY MAY BE A CONTRIBUTING FACTOR. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION RESULTS/CONCLUSIONS: BUSHING EXHIBITS FRACTURE DAMAGE BELOW FLANGE. INSIDE & OUTSIDE DIAMETER APPEAR TO HAVE BEEN DEFORMED & ARE OF AN ELLIPTICAL SHAPE. HINGE POST EXTENSION EXHIBITS BURNISHING MARKS TO OUTSIDE DIAMETER & MEETS DIMENSIONAL SPECIFICATION. SURFACE EXHIBITS SLIGHT WEAR TO CONDYLES & GOUGING/DEFORMATION DAMAGE TO INFERIOR SIDE & POSTERIOR RIM. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF SURFACE SHOWED A CARBON (C) PEAK IN SPECTRUM TYPICAL OF UHMWPE. THIRD BODY PARTICULES SHOWING C, K, CI, NA, AL, SI, O, AND TI WERE OBSERVED. MANUFACTURING RECORDS ARE INTACT, CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THE DEVICE WAS IMPLANTED IN 2005. IN 2006, PATIENT HEARD A "POP" WHEN SHE PUT WEIGHT ON HER LEG UPON STANDING FROM HER WHEELCHAIR. AFTERWARDS SHE WAS UNABLE TO BEAR WEIGHT ON THE LEG AND HER TIBIA EXTERNALLY ROTATED. PATIENT PRESENTED WITH A COMPLETELY ASSEMBLED BUT DISARTICULATED KNEE JOINT. X-RAYS CONFIRMED THE FEMORAL HINGE PIN EXTENSION AND TIBIAL PROSTHESIS CONSTRUCT HAD DISENGAGED. DEVICE WAS REVISED ON THE NEXT DAY, WHERE IT WAS CONFIRMED THE HINGE PIN EXTENSION AND ARTICULAR SURFACE COMPONENTS HAD COME APART FROM THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR KNEE PROSTHESIS JWH ZIMMER, INC. NA 60235810

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R