BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE STD D42MM

    MDR report key: 2860904 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-83202
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 29, 2012
    Report Date
    October 13, 2014
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWS
    PMA / PMN Number
    PK062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE COMMUNICATED ELEMENTS, NO ANALYSIS COULD BE CARRIED OUT BECAUSE NO SUFFICIENT INFORMATION WAS PROVIDED ( NO PRODUCT RETURNED, NO BATCH NUMBER COMMUNICATED).

    Additional Manufacturer Narrative · 1

    LOT # (5118293); EXPIRY DATE (MAR 1, 2017), PMA/510(K) # (K062250), MANUFACTURE DATE (APR 26, 2012), (B)(4). THE INVESTIGATION IS ONGOING. 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

    FROM THE COMMUNICATED ELEMENTS, NO ANALYSIS COULD BE CARRIED OUT BECAUSE NO SUFFICIENT INFORMATION WAS PROVIDED (NO PRODUCT RETURNED, NO BATCH NUMBER COMMUNICATED). UPDATE DEPUY (B)(4) 21 OCTOBER 2014: BATCH NUMBERS PROVIDED. DHR AND STERILE CERTIFICATES WERE REVIEWED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    THE PATIENT UNDERWENT A WASHOUT OF A DELTA XTEND TOTAL SHOULDER REPLACEMENT DUE TO INFECTION. THE WOUND WAS REOPENED AND IRRIGATED WITH SALINE. THE GLENOSPHERE AND HUMERAL LINER WERE REMOVED AND THE REMAINING IMPLANTS WERE THEN IRRIGATED. A NEW GLENOSPHERE AND HUMERAL LINER WERE THEN IMPLANTED AND THE WOUND WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND GLENOSPHERE STD D42MM DEPUY SHOULDER IMPLANT KWS DEPUY FRANCE 5118293

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention