BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY

    MDR report key: 4401868 · Received January 8, 2015

    Report

    Report Number
    4401868
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 1, 2014
    Report Date
    December 9, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD REVISION OF LEFT TOTAL HIP REPLACEMENT WITH REMOVAL AND EXCHANGE OF ACETABULAR COMPONENT AND FEMORAL HEAD. INCREASED BLOOD COBALT AND CHROMIUM LEVELS. MRI SUGGESTS ADVERSE REACTION TO METAL. COMPONENTS IDENTIFIED AS FOLLOWS: FEMORAL IMPLANT: REF 9998-90-249; LOT 2199714, SIZE 49; EXP 2011-07. ACETABULAR CUP: REF 9998-00-756; LOT 2173630, SIZE 56, EXP 2011-07. PLEASE REFERENCE REPORT MFR REPORT NUMBERS: 1818910-2015-10473 AND 1818910-2015-10474.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15581 DEPUY FEMORAL IMPLANT, SIZE 49 KWA DEPUY ORTHOPAEDICS, INC 2199714
    15582 DEPUY ACETABULAR CUP, SIZE 56 KWA DEPUY ORTHOPEDICS, INC. 2173630

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR