BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED (LPS) ARTICULAR S

    MDR report key: 1211757 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00732
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 10, 2008
    Report Date
    September 2, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS RETURNED, THE ARTICULAR SURFACE COMPONENT DISPLAYED SLIGHT WEAR AND PITTING ON THE ARTICULAR SURFACE CONSISTENT WITH THE DURATION OF IMPLANTATION. SMALL GOUGES WERE OBSERVED ON THE BACKSIDE OF THE SURFACE. IT IS PROBABLY THAT THE GOUGES WERE CREATED BY THE EXTRACTION INSTRUMENT DURING REMOVAL OF THE ARTICULAR SURFACE FROM THE TIBIAL COMPONENT. LABORATORY EXAMINATION USING SCANNING ELECTRON MICROSCOPY ANALYSIS (SEM) CONFIRMED THAT THE MATERIAL IS UHMWPE. SEM ANALYSIS DID NOT INDICATE PRESENCE OF 3RD BODY PARTICLES (BONE CEMENT). EVALUATION: DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY ANALYSIS (SEM)/ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS EXPLANTED IN 2008. INSERT EXCHANGED AFTER PHYSICIAN DECIDED TO DEBRIS PATIENT'S KNEE - NO INFECTION PRESENT. DEVICE WAS IMPLANTED IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED (LPS) ARTICULAR S KNEE PROSTHESIS JWH ZIMMER, INC. NA 60009841

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R