BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KX PLUS FEM CONDY NONPOR XLG

    MDR report key: 184752 · Received August 27, 1998

    Report

    Report Number
    9610726-1998-00120
    Event Type
    Malfunction
    Date Received
    August 27, 1998
    Report Date
    August 26, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT THE PATIENT EXPERIENCED PAIN AND SWELLING. X-RAYS REVEALED A METALLIC PARTICLE. IT IS THE SURGEON'S BELIEF THAT THIS MAY BE CAUSED BY METAL-TO-METAL CONTACT. THE PRODUCT IS STILL IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX PLUS FEM CONDY NONPOR XLG Implant IMPLANT HSA HOWMEDICA INC. NA LIDRO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other