BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY HIP LINER

    MDR report key: 4091613 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28138
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, POLY WEAR, AND FRACTURED LINER. (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITHOUT DEVICE EXAMINATION. HOWEVER ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, POLY WEAR, AND FRACTURED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570995 UNKNOWN DEPUY HIP LINER HIP ACETABULAR INSERT/LINER KWA 1818910 DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention