BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE STD D42MM

    MDR report key: 2535634 · Received April 13, 2012

    Report

    Report Number
    1818910-2012-10041
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 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 CODE REQUIRED FOR THE CUP WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR BOTH THE GLENOSPHERE AND METAGLENE PART AND LOT NUMBER COMBINATIONS. 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 TO ADDRESS DISASSOCIATION OF THE GLENOSPHERE FROM THE METAGLENE. POLY WEAR WAS ALSO REPORTED. (LEFT SHOULDER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND GLENOSPHERE STD D42MM EXTREMITY IMPLANT HSD DEPUY FRANCE 5032514

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention