BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2213258 · Received August 12, 2011

    Report

    Report Number
    MW5021723
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 1, 2010
    Report Date
    August 12, 2011
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT HIS WIFE HAD A HIP PROSTHESIS INSERTED ABOUT 1 YEAR AGO. REPORTER SAID THAT HIS WIFE RETURNED TO THE DR'S OFFICE SEVERAL TIMES FOR ABOUT 5 MONTHS DUE TO DISCOMFORT. REPORTER STATED THAT NOTHING WAS BEING DONE, SO THEY WENT TO ANOTHER DR WHO REMOVED THE DEVICE. IT WAS DISCOVERED THAT THE GLUE THAT SECURES THE DEVICE HAD COME OUT. IT WAS ALSO DISCOVERED THAT THERE WAS AN INFECTION PRESENT. REPORTER'S WIFE IS CURRENTLY UNDERGOING TREATMENT FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN HIP PROSTHESIS JDI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR