BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DURALOC ACETABULAR LINER

    MDR report key: 3792433 · Received May 6, 2014

    Report

    Report Number
    1818910-2014-18149
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272299 UNKNOWN DEPUY DURALOC ACETABULAR LINER HIP ACETABULAR LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention