BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER UNICOMPARTMENTAL KNEE SYSTEM ARTICULAR SURFACE

    MDR report key: 1150089 · Received August 29, 2008

    Report

    Report Number
    1822565-2008-00557
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 20, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007. DURING THE 12 MONTH FOLLOW UP, PATIENT HAS PRESENTED WITH PAINFUL KNEE WHICH WILL NOT FLEX DUE TO PAIN. THE X-RAYS SHOW SEVERE OSTEOLYSIS BELOW THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNICOMPARTMENTAL KNEE SYSTEM ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. NA 60567952

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK