BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC CONST LINER 50X28

    MDR report key: 3900355 · Received June 27, 2014

    Report

    Report Number
    1818910-2014-22233
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    JDI
    PMA / PMN Number
    PP960054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO NOTED THAT THE LOCKING RING HAD COMPLETELY DETACHED. *SURGEON REPORTED THAT IT WAS CAUSED BY A FALL.* DOI: UNKNOWN - DOR: (B)(6) 2014 (UNKNOWN HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE 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 WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO NOTED THAT THE LOCKING RING HAD COMPLETELY DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376759 DURALOC CONST LINER 50X28 HIP ACETABULAR INSERT/LINER JDI DEPUY ORTHOPAEDICS, INC.-1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention