BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR

    MDR report key: 982220 · Received January 18, 2008

    Report

    Report Number
    1822565-2008-00028
    Event Type
    Injury
    Date Received
    January 18, 2008
    Date of Event
    November 28, 2007
    Report Date
    December 17, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AS RETURNED, THE ARTICULAR SURFACE COMPONENT SHOWS EXCESSIVE WEAR AND PITTING ON THE CONDYLE SURFACES AS WELL AS AROUND THE BASE OF THE SPINE. ALSO, THE PART SHOWS ROTATIONAL STRIATIONS ON THE BACK SIDE SURFACE, DOVETAIL LIP DEFORMATION AND DEEP GOUGING MARKS NEAR THE NOTCH. LAB EXAMINATION USING SCANNING ELECTRON MICROSCOPE INDICATES THE PRESENCE OF BONE CEMENT PARTICLES ON THE CONDYLE SURFACES OF THE POLYETHYLENE COMPONENT THAT COULD HAVE LED TO 3RD BODY PARTICLE WEAR/PITTING. FURTHERMORE, THE MFG RECORDS SHOW THAT THE DEVICE WAS MFG AND PACKAGED TO SPECIFICATIONS. THE CAUSE OF THE WEAR NOTED ON THE ARTICULATING SURFACES CANNOT BE DEFINITIVELY DETERMINED; HOWEVER, THE PRESENCE OF BONE CEMENT PARTICLES FOUND ON THE SURFACES COULD HAVE BEEN A CONTRIBUTING FACTOR. EVAL: AS RETURNED, THE ARTICULAR SURFACE EXHIBITS HEAVY DELAMINATION TO BOTH CONDYLE SURFACES AND TO THE MEDIAL SPINE. ADDITIONALLY, THE DEVICE HISTORY RECORDS ARE INTACT AND CONFORMING, INDICATING THE DEVICE WAS MFG TO SPECIFICATIONS. SCANNING ELECTRON MICROSCOPY EXAMINATION OF THE ARTICULATING SURFACE WAS CONDUCTED AND WEAR DAMAGE WAS DOCUMENTED. PITTING, MICRO CRACKS AND MATERIAL LOSS FROM THE ARTICULATING SURFACE WAS OBSERVED. THIRD BODY WEAR PARTICLES WERE ALSO SEEN SHOWING C, O, P, S AND CA PEAKS IN THE SPECTRUM. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE ARTICULATING SURFACE MATERIAL SHOWED A CARBON (C) PEAK TYPICAL OF UHMWPE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR KNEE PROSTHESIS HSA ZIMMER, INC. NA 50390000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R