BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND GLENOSPHERE STD D38MM

    MDR report key: 3913945 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22666
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    DEPUY FRANCE SAS - SAINT PRIEST 3003895575
    Product Code
    HSD
    PMA / PMN Number
    PK062250
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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.

    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

    A DEPUY FRANCE SUPPLIER EXAMINED THE RETURNED PRODUCT AND CONFIRMED THE COMPLAINT. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR; INCORRECT ASSEMBLY OF MATING COMPONENTS. 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. 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    SURGEON WAS UNABLE TO SCREW THE GLENOSPHERE INTO PLACE, AFTER REMOVING THE GLENOSPHERE, METAL DEBRIS WAS FOUND AROUND THE ENTRY HOLE ON THE METAGLENE. SURGEON TRIED TO SCREW THE GLENOSPHERE AGAIN BUT WAS UNSUCCESSFUL. A NEW SAME SIZE SAME LIKE IMPLANT WAS OPENED ANOTHER AND SURGEON WAS ABLE TO CORRECTLY THREAD THE GLENOSPHERE INTO PLACE. DELAY OF 5 MINUTES. NO AE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389447 DXTEND GLENOSPHERE STD D38MM SHOULDER HEAD/GLENOSPHERE HSD DEPUY FRANCE SAS - SAINT PRIEST 3003895575 5224622

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention