BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE - POSTERIOR STABILIZED ARTICULAR SURFA

    MDR report key: 1060413 · Received June 12, 2008

    Report

    Report Number
    1822565-2008-00310
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 7 YEARS POST-OP DUE TO BREAKAGE OF THE ARTICULAR SURFACE SPINE. THE AGE, WEIGHT AND THE ACTIVITY LEVEL OF THE PATIENT ARE NOT KNOWN. AS RETURNED, THE ARTICULAR SURFACE SHOWS THAT THE SPINE HAS FRACTURED OFF FROM THE BASE. THE FRACTURED FRAGMENT SHOWS BOW TIE SHAPE DEFORMATION DAMAGE ON IT'S ANTERIOR SIDE. THE DAMAGE INDICATES THAT THE FEMORAL COMPONENT WAS IMPINGING UPON IT DURING ARTICULATION AND CAUSED DAMAGE. ALSO, X-RAYS ARE NOT AVAILABLE FOR REVIEW. LABORATORY EXAMINATION USING SEM ON THE FRACTURED ARTICULAR SURFACE SHOWS STRIATED FEATURES INDICATING FRACTURE OCCURRED BY FATIGUE. ALSO, THE CRACK APPEARS TO HAVE PROPAGATED FROM ANTERIOR TO POSTERIOR SIDE. LOT NUMBER OF THE DEVICE IS NOT KNOWN AND THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE OF SPINE FRACTURE COULD NOT BE DEFINITELY DETERMINED BASED ON THE AVAILABLE INFO. EVALUATION: THE RETURNED DEVICE MEETS SPECIFICATION WHERE MEASURABLE ON ITS CURRENT CONDITION. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE ARTICULATING SURFACE SPINE FRACTURE SHOWED STRIATED FEATURES INDICATING THAT FRACTURE OCCURRED BY FATIGUE. PART OF FRACTURE APPEARED POLISHED PROBABLY DUE TO RUBBING OF OPPOSITE SURFACES ERASING SOME OF THE STRIATED FEATURES. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS SHOWED A CARBON PEAK IN THE SPECTRUM, TYPICAL OF UHMWPE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2001. REVISION SURGERY OCCURRED IN 2008, DUE TO BREAKAGE. EXACT IMPLANT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE - POSTERIOR STABILIZED ARTICULAR SURFA KNEE PROSTHESIS JWH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R