BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ELITE HYL CUP

    MDR report key: 381405 · Received March 14, 2002

    Report

    Report Number
    1818910-2002-00135
    Event Type
    Injury
    Date Received
    March 14, 2002
    Date of Event
    September 6, 2001
    Report Date
    March 14, 2002
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REVISED DUE TO EARLY POLY WEAR AND LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ELITE HYL CUP TOTAL HIP PROSTHESIS KWY DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention