BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 +3MM

    MDR report key: 4113756 · Received September 24, 2014

    Report

    Report Number
    1818910-2014-28762
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWS
    PMA / PMN Number
    PK120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION STATES THAT ONLY THE GLENOSPHERE (PRODUCT CODE 130760038/ LOT 5211132)AND THE STANDARD HUMERAL CUP (PRODUCT CODE 130738203/ LOT 52247084) WERE REMOVED. THE DHR ANALYSIS OF BATCH 5211132 AND 52247084 (THE IMPLANTS REMOVED) SHOWS AN INITIAL CONFORMANCE OF THESE PRODUCTS WITH REGARDS TO THEIR SPECIFICATION. FOR THESE BATCHES, THERE WAS NO DEVIATION OR NON-CONFORMANCE. THE STERILE CERTIFICATES WERE REVIEWED. NO ANOMALY WAS DETECTED. NO OTHER ANALYSIS WAS POSSIBLE BECAUSE THE PRODUCTS OR X-RAYS WERE NOT RETURNED. THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. A REGULAR FOLLOW UP OF THE ISSUE IS PERFORMED THROUGH POST MARKET SURVEILLANCE REVIEWS AS PER SEP 419. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CORRECTED: 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

    PROCEDURE: REVISION DELTA XTEND SHOULDER ARTHROPLASTY PERFORMED ON (B)(6) 2014. PRIMARY SURGERY DATE: (B)(6) 2014. REVISION SURGERY PERFORMED BECAUSE OF A QUESTION OF INFECTION. THE GLENOSPHERE AND THE STANDARD HUMERAL CUP WERE REMOVED. THE WOUND AND REMAINING IMPLANTS WERE IRRIGATED AND A NEW GLENOSPHERE AND HUMERAL CUP WERE IMPLANTED. IMPLANTS WERE DISCARDED AS PER HOSPITAL POLICY. PRE OP X-RAYS, PRIMARY AND REVISION NOTES ARE NOT AVAILABLE BECAUSE THE PATIENT DID NOT GIVE CONSENT FOR ATTAINING THESE NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594968 DXTEND STAND PE CUP D38 +3MM SHOULDER BEARING KWS DEPUY FRANCE SAS - 3003895575 52247084

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention