BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE/DEPUY

    MDR report key: 472513 · Received July 18, 2003

    Report

    Report Number
    472513
    Event Type
    Injury
    Date Received
    July 18, 2003
    Date of Event
    July 14, 2003
    Report Date
    July 16, 2003
    Manufacturer
    DEPUY ORTHOPEDICS, INC
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/26/03: AFTER FOLLOWING UP WITH THE REPORTING HOSPITAL, TWO DEPUY PRODUCTS WERE IDENTIFIED; 1. 1241-54-526 (POLYETHYLENE LINER), AND 2. 1365-13-000 (FEMORAL HEAD). THE LOT NUMBER FOR THE TWO DEVICES LISTED ABOVE ARE VH6CJ1 (POLYETHYLENE LINER) AND 1073553 (FEMORAL HEAD). DEPUY'S MDR DECISION PROCESS FOUND THIS EVENT (REVISION DUE TO DISLOCATION/PAIN) TO BE NOT -REPORTABLE, AND NO REPORT WAS SUBMITTED.

    Description of Event or Problem · 1

    ORIGINAL RIGHT HIP REPLACEMENT IN 2003. REQUIRED REVISION OF RIGHT HIP ARTHROPLASTY 2 MONTHS LATER DUE TO CHRONIC DISLOCATION AND PAIN. ITEMS REMOVED: METAL BALL, SHELL LINER, SCREWS-X2 FOR CUP STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE/DEPUY HIP ARTHROPLASTY, METAL BALL - 54MM JDI DEPUY ORTHOPEDICS, INC * W39EF1
    2 ACE/DEPUY HIP ARTHROPLASTY, BALL - 28 + 8.5 JDI DEPUY ORTHOPEDICS, INC. * 1073553C
    3 ACE/DEPUY HIP ARTHROPLASTY, SHELL LINER - 28L 54 + 4 KWB DEPUY ORTHOPEDICS, INC. * VH6CJ1
    4 ACE/DEPUY HIP ARTHROPLASTY, SCREWS - X2 FOR CUP STABILITY HWC DEPUY ORTHOPEDICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention