BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML/TL HYL REP LINER 32X44SP

    MDR report key: 506392 · Received January 14, 2004

    Report

    Report Number
    1818910-2004-00025
    Event Type
    Injury
    Date Received
    January 14, 2004
    Report Date
    December 15, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT REVISED FOR POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML/TL HYL REP LINER 32X44SP TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA 375380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention