BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA

    MDR report key: 1065888 · Received June 24, 2008

    Report

    Report Number
    1822565-2008-00354
    Event Type
    Injury
    Date Received
    June 24, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS REPORTED THAT THE LPS FLEX ARTICULAR SURFACE WAS IMPLANTED IN 2005 AND THE PT FELL IN 2007, AND THE KNEE BECAME UNSTABLE. DURING REVISION SURGERY. IT WAS FOUND THAT THE ARTICULAR SURFACE SPINE HAD BROKEN. ALSO, THE POLY WAS FOUND TO HAVE PITTING DAMAGE. THE PT IS A FEMALE AND HAD MEDIUM ACTIVITY LEVEL. THE AGE OF THE PT IS NOT KNOWN. AS RETURNED, THE SPINE HAS FRACTURED OFF FROM THE BASE. LABORATORY EXAMINATION USING SEM WAS CONDUCTED ON THE SPINE FRAGMENT TO EVALUATE THE MATERIAL FAILURE PATTERN AND THE FRACTURE APPEARS TO HAVE OCCURRED BY FATIGUE. ALSO, THE CRACK APPEARS TO HAVE PROPAGATED FROM ANTERIOR TO POSTERIOR SIDE. ANTERIOR SURFACE ON THE SPINE FRAGMENT SHOWS MATERIAL DEFORMATION IN BOW-TIE SHAPE ON THE DISTAL END. ALSO, SEM ANALYSIS INDICATES THE PRESENCE OF THIRD BODY PARTICLES ON THE ARTICULATING SURFACES OF THE POLYETHYLENE COMPONENT THAT COULD HAVE LEAD TO 3RD BODY PARTICLE WEAR/PITTING. IT IS LIKELY THAT THE IMPACT OF FALL CAUSED THE SPINE FRACTURE AND THE PRESENCE OF BONE CEMENT PARTICLES FOUND ON THE SURFACES COULD HAVE BEEN A CONTRIBUTING FACTOR FOR THE PITTING DAMAGE. EVAL: THE DEVICE MEETS SPECIFICATION WHERE MEASURABLE IN ITS CURRENT CONDITION. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE SPINE FRACTURE SURFACE SHOWED STRIATED FEATURES INDICATING THAT FRACTURE OCCURRED BY FATIGUE. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS SHOWED A CARBON PEAK IN THE SPECTRUM THAT IS TYPICAL OF AN UHMWPE MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2005. PT FELL IN 2007 AND THE KNEE BECAME UNSTABLE. REVISION SURGERY OCCURRED THE FOLLOWING MONTH, WHERE IT WAS DISCOVERED THAT THE ARTICULAR SURFACE SPINE HAD BROKEN. IT WAS ALSO DISCOVERED THAT THE POLY WAS PITTED. EXACT IMPLANT DATE IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R