BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR (LCCK) ARTICULAR

    MDR report key: 1001016 · Received February 20, 2008

    Report

    Report Number
    1822565-2008-00060
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE LOCKING SCREW HAS FRACTURED OFF FROM THE THREADED END. ARTICULAR SURFACE SHOWS SLIGHT WEAR AND PITTING MARKS ON THE ARTICULAR SURFACES WHICH APPEAR TO BE CONSISTENT WITH THE 5 YEARS 5 MONTHS OF IMPLANTATION. THE POSTERIOR EDGES OF THE SPINE HAS BOW-TIE SHAPE DEFORMATION INDICATING THAT THE FEMUR WAS HITTING THE SPINE IN HYPER-EXTENSION. THE BACK SURFACE OF THE ARTICULAR SURFACE SHOWS GOUGING, SCRATCH MARKS AND MATERIAL DEFORMATION ON THE ANTERIOR SIDE. ALSO, THE LOCKING TABS ON THE POSTERIOR SIDE AND DOVETAIL LIPS ARE CRUSHED. IT APPEARS THAT THE ARTICULAR SURFACE BECAME LOOSE AND JOINT WAS UNSTABLE WHICH RESULTED IN THE DAMAGE TO THE POLY PART. PRE-OP X-RAYS ARE NOT AVAILABLE TO REVIEW. THE CAUSE OF THE SCREW FRACTURE COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFO. EVALUATION: AS RETURNED, THE LOCKING SCREW HAS FRACTURED AT APPROX THE FOURTH THREAD FROM THE DISTAL END OF THE DEVICE. THE ARTICULAR SURFACE EXHIBITS SOME MINOR PITTING ON THE CONDYLE SURFACES AND SOME WEAR TO THE BACKSIDE OF THE DEVICE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE INTACT AND CONFORMING, INDICATING THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE FRACTURE SURFACE OF THE SCREW SHOWED FATIGUE STRIATIONS INDICATING THAT THE FRACTURE OCCURRED BY FATIGUE. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE SCREW MATERIAL SHOWED TI, AL AND V PEAKS IN THE SPECTRUM TYPICAL OF A TIVANIUM ALLOY.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2002. PT PRESENTED WITH LOCKED KNEE. X-RAY DETERMINED LOCKING SCREW WAS BROKEN AND WAS NO LONGER IN POSITION. ARTICULAR SURFACE WAS REMOVED AND REPLACED ALONG WITH THE SCREW DURING REVISION SURGERY IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR (LCCK) ARTICULAR KNEE PROSTHESIS JWH ZIMMER, INC. NA 41164600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R