BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER

    MDR report key: 1900966 · Received October 29, 2010

    Report

    Report Number
    MW5018190
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    June 12, 2009
    Report Date
    October 28, 2010
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT ON (B)(6), 2009. CONTINUED PAIN AND SWELLING. LIMITED WALKING, UNABLE TO SLEEP AT NIGHTS. ORTHOPEDIC DOCTOR HAS REFERRED ME TO CLEVELAND CLINIC FOR REVISION AND/OR REPLACEMENT. APPT IS (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 JWH ZIMMER 61166957
    2 ZIMMER NEXGEN COMPLETE KNEE SOLUTION CR-FLEX GSF FEMORAL COMPONENT PRECOAT SIZE D MINUS MBH ZIMMER 61066352
    3 ZIMMER NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA STANDARD JWH ZIMMER 61169282
    4 ZIMMER NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE CRUCIATE RETAINING (CR) PROLONG JWH ZIMMER 61091120
    5 ZIMMER PALACOS R +G RADIOPAQUE BONE CEMENT WITH GENTAMICIN MBB ZIMMER 68164202

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR