BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE ECC D38MM

    MDR report key: 2571299 · Received May 11, 2012

    Report

    Report Number
    1818910-2012-12556
    Event Type
    Injury
    Date Received
    May 11, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 24, 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 AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A DEPUY FRANCE SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX C. TERRITORY OFFICE COMMUNICATED NO ADDITIONAL INFORMATION IS AVAILABLE. PROVIDED INFORMATION STATES A REVERSE SHOULDER WAS PUT INTO THE PATIENT FOR A FRACTURED SHOULDER. THE SHOULDER DISLOCATED AND THE SURGEON PUT IN A SPACER AND A THICKER POLY TO KEEP IT STABLE. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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 DISLOCATION. (SHOULDER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND GLENOSPHERE ECC D38MM EXTREMITY IMPLANT HSD DEPUY FRANCE 5101257

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention