BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND METAGLENE

    MDR report key: 2834106 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-27766
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    HSD
    PMA / PMN Number
    K602250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS 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 C. TERRITORY OFFICE COMMUNICATED NO ADDITIONAL INFORMATION IS AVAILABLE. PROVIDED INFORMATION FROM THE REP STATES THE GLENOSPHERE WAS NOT SECURED ON THE METAGLENE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE, THE GLENOSPHERE HAD LOOSENED FROM THE METAGLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND METAGLENE GLENOID PROSTHESIS HSD DEPUY FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention