BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1007110 · Received March 4, 2008

    Report

    Report Number
    1822565-2008-00082
    Event Type
    Injury
    Date Received
    March 4, 2008
    Date of Event
    August 8, 2006
    Report Date
    February 6, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. THE ANTERIOR SURFACE ON THE SPINE FRAGMENT SHOWS MATERIAL DEFORMATION IN BOW-TIE SHAPE ON THE DISTAL END. FURTHER, THE MFG RECORDS SHOW THAT THE DEVICE WAS MANUFACTURED AND PACKAGED TO SPECS. IT'S LIKELY THAT THE SPINE FRACTURED DUE TO ABNORMAL AP ARTICULATION OF THE FEMORAL COMPONENT CAUSING ANTERIOR IMPACT AND MATERIAL FATIGUE BUT THE CAUSE COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. ONLY THE FRACTURED SPINE WAS RETURNED FOR REVIEW. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE FRACTURE SURFACE WAS CONDUCTED ON THE BROKEN SPINE OF THE ARTICULATING SURFACE. THE ARTICULATING SURFACE WAS NOT RECEIVED FOR EXAMINATION. STRIATED FEATURES OBSERVED ON THE FRACTURE SURFACE INDICATED THAT FRACTURE OCCURRED BY FATIGUE. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE SPINE MATERIAL SHOWED A CARBON (C) PEAK IN THE SPECTRUM TYPICAL OF UHMWPE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PT THAT HE UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY IN 2001. POST-OP, THE PT EXPERIENCED PAIN AND SYNOVITIS. THE PT WAS REVISED IN 2006, WHEREIN FRACTURE AND A SQUARE CENTIMETER LOOSE BODY OF THE TIBIAL COMPONENT WAS NOTED.

    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 69495300

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R