BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE STD D38MM

    MDR report key: 3040630 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-15039
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    3003895575 DEPUY FRANCE
    Product Code
    KWS
    PMA / PMN Number
    PK120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING PATIENT X-RAYS, BUT WERE NOT PROVIDED TO CUSTOMER QUALITY. THE DHR ANALYSIS OF THE BATCHES INDICATED SHOWS AN INITIAL CONFORMANCE OF THESE PRODUCTS WITH REGARDS TO THEIR SPECIFICATION. FOR THESE BATCHES, THERE WAS NO DEVIATION OR FAILURE INVESTIGATION REPORT. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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.

    Description of Event or Problem · 1

    REASON FOR REVISION: PATIENT FELL OVER AND FRACTURED THEIR GLENOID AND SUBSEQUENTLY DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143727 DXTEND GLENOSPHERE STD D38MM GLENOSPHERE KWS 3003895575 DEPUY FRANCE 5202177

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention