BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE STD D38MM

    MDR report key: 1972510 · Received January 26, 2011

    Report

    Report Number
    1818910-2011-00585
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    DEPUY FRANCE S.A
    Product Code
    KWS
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. 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. 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

    PT PRESENTED TO HOSP WITH PAIN AND SWELLING TO SHOULDER. FOLLOWING INVESTIGATIONS, PT DIAGNOSED WITH DEEP TISSUE INFECTION AND PRESCRIBED INTRAVENOUS ANTIBIOTICS. INITIALLY PERFORMED A WOUND WASHOUT WITH LITTLE IMPROVEMENT. ON (B)(6) 2010 - DEVICE EXCHANGE. INFECTED MEMBRANE REMOVED FROM THE UNDERSIDE OF BOTH IMPLANTS AND SENT FOR PATHOLOGY, RESULTS PENDING. THERE WAS NO EVIDENCE OF LOOSE COMPONENTS AS THE TIME OF REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND GLENOSPHERE STD D38MM 87KWS 87HSD KWS DEPUY FRANCE S.A NA 5037720

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention