BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR NEUT LNR 32IDX52OD

    MDR report key: 8165868 · Received December 14, 2018

    Report

    Report Number
    1818910-2018-78294
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    November 19, 2018
    Report Date
    November 19, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KPH
    UDI-DI
    10603295015451
    PMA / PMN Number
    K994415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    REVISION DUE TO PAIN AND WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004794 DUR MAR NEUT LNR 32IDX52OD DURALOC IMPLANT : HIP POLY ACETABULAR LINERS KPH DEPUY ORTHOPAEDICS INC US 10603295015451

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention