BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2052196 · Received April 10, 2011

    Report

    Report Number
    2052196
    Event Type
    Malfunction
    Date Received
    April 10, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 10, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS HAD FIVE REVISIONS OF A RIGHT TOTAL KNEE ARTHROPLASTY WITH A MOST RECENT SURGERY DONE BY AN OUTSIDE HOSPITAL (OSH) SEVERAL YEARS AGO. TO DATE, ALL OF HIS INFECTION WORKUPS HAVE BEEN NEGATIVE. HE HAD AN ARTHROGRAM RECENTLY. THERE WAS INCREASED UPTAKE ALONG THE FEMORAL COMPONENT CONSISTENT OR SUGGESTIVE OF LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FEMORAL COMPONENT, POLY INSERT JWH WRIGHT MEDICAL TECHNOLOGY * *
    2 * FEMORAL COMPONENT, LINK JWH WRIGHT MEDICAL TECHNOLOGY CE-0123 07080270159

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR