BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY

    MDR report key: 4003018 · Received August 12, 2014

    Report

    Report Number
    4003018
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 1, 2014
    Manufacturer
    DEPUY ORTHOPEDICS, 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 LEFT TOTAL HIP ARTHROPLASTY REVISION DUE TO LINER DISSOCIATION FROM ACETABULAR COMPONENT. FEMORAL HEAD: (B)(4); LOT: 2391808; EXP: 05/2012; 32 MM +1. ACETABULAR LINER: (B)(4); LOT: A5KCV100; 54MM OD 32MM ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478063 DEPUY FEMORAL HEAD 32MM +1 KWA DEPUY ORTHOPEDICS, INC. 1365-21-000 2391808
    478064 DEPUY ACETABULAR LINER 54MM OD 32MM ID KWA DEPUY ORTHOPEDICS, INC. 1219-32-254 A5KCV100

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other