BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNG

    MDR report key: 17948829 · Received October 17, 2023

    Report

    Report Number
    3003898228-2023-00012
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    November 17, 2020
    Report Date
    October 10, 2023
    Manufacturer
    FH INDUSTRIE
    Product Code
    LPH
    PMA / PMN Number
    K021109
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FH INDUSTRIE PROCEDURES DID NOT CLEARLY DEFINE THE RULES FOR REPORTING INCIDENTS TO FDA WHEN THE DEVICES WERE NO LONGER BEING DISTRIBUTED INTO THE US MARKET. THE VIGILANCE OFFICER AT THE TIME WAS UNAWARE THAT THESE REPORTING RULES HAD TO BE APPLIED EVEN TO PRODUCTS THAT WERE NO LONGER DISTRIBUTED IN THE UNITED STATES AND THAT WERE INACTIVATED IN THE FDA REGISTRATION & LISTING DATABASE. THE MEDWATCH REPORTS THAT WERE NOT FILED ARE NOT CONNECTED TO ANY RECALLS AND HAD NO IMPACT ON PATIENT SAFETY. A CAPA WAS OPENED TO DETERMINE ROOT CAUSE AND CORRECTIVE ACTION.

    Description of Event or Problem · 0

    HOSPITALISATION IN GENERAL MEDICINE FOR HIP PAIN ON LEFT PROSTHESIS: SUSPECTED METALLOSIS PATIENT'S CURRENT CONDITION : HIP PAIN. BLOOD CHROMIUM AND COBALT LEVELS WELL ABOVE NORMAL. PELVIC X-RAY REVEALED MULTIPLE DIFFUSE CALCIFIED MASSES IN THE ILIAC PSOAS G MUSCLE. MUSCLE BIOPSY REVEALED A BLACK LIQUID. CRCO TOTAL HIP REPLACEMENT IMPLANTED ON (B)(6) 2016. ACTIONS UNDERTAKEN IN THE CARE FACILITY FOR THE MANAGEMENT OF THE PATIENT: SCHEDULING AT THE BEGINNING OF DECEMBER REMOVAL OF THE LEFT HIP PROSTHESIS. THE PROSTHESIS IS DUE TO BE REPLACED ONCE THE BLOOD LEVELS OF CHROMIUM AND COBALT HAVE BEEN REGULARISED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739112 HNG COCR FEMORAL HEAD D28 12/14 D28 M (+0) USA LPH FH INDUSTRIE RG01761

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown