BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC 28MM ID NEUT HYLAMER

    MDR report key: 125440 · Received October 6, 1997

    Report

    Report Number
    1818910-1997-00199
    Event Type
    Injury
    Date Received
    October 6, 1997
    Date of Event
    August 6, 1997
    Report Date
    September 11, 1997
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ANOTHER CATALOG NUMBER WAS INVOLVED IN THIS EVENT: CATALOG NUMBER, 124648000, LOT NUMBER 765090, MFR DATE, 03/16/1995. BOTH CATALOG NUMBERS ARE ON THE INITIAL BASELINE REPORT SUBMITTED 10/11/1996 UNDER 1818910-1996-00035. THE INVESTIGATION IS STILL ON-GOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    COMPLAINANT CLAIMS THE ACETABULAR POLYETHYLENE LINER FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC 28MM ID NEUT HYLAMER Implant TOTAL HIP PROSTHESIS KWB DEPUY ORTHOPAEDICS, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention