BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M BATEMAN UPFII OUTER HEAD/BEARING INSERT

    MDR report key: 412496 · Received August 14, 2002

    Report

    Report Number
    2110898-2002-00010
    Event Type
    Malfunction
    Date Received
    August 14, 2002
    Date of Event
    January 10, 2002
    Report Date
    August 13, 2002
    Manufacturer
    3M HEALTH CARE LTD./HELLABY INDUSTRIAL ESTATE
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED AN IMPLANT REVISION DUE TO PAIN. THE HEAD AND STEM OF THE IMPLANT HAD DISENGAGED FROM THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M BATEMAN UPFII OUTER HEAD/BEARING INSERT BIPOLAR HIP PROSTHESIS JDI 3M HEALTH CARE LTD./HELLABY INDUSTRIAL ESTATE 55.5MMDB15610AA SAME AS SERIAL NUMBER

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention