BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CTD HUM EPI.42.2

    MDR report key: 2574107 · Received May 15, 2012

    Report

    Report Number
    1818910-2012-12796
    Event Type
    Injury
    Date Received
    May 15, 2012
    Date of Event
    March 29, 2012
    Report Date
    May 13, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWS
    PMA / PMN Number
    K021478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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

    EXAMINATION OF THE RETURNED PRODUCT BY DEPUY FRANCE FINDS NO PRODUCT PROBLEM HAS BEEN IDENTIFIED. REVIEW OF PROVIDED PATIENT X-RAYS BY A DEPUY FRANCE ENGINEER FINDS THE TUBEROSITIES DIDNT HEAL PROPERLY, THEN, THE JOINT FORCES WERE APPLIED ON THE HUMERAL IMPLANT CONNECTION, LEADING TO THE FAILURE OF THIS CONNECTION. THIS CONCERN HAS BEEN TAKEN INTO ACCOUNT IN THE DELTA XTEND PROSTHESIS BY PROVIDING A MONOBLOC HUMERAL IMPLANT FOR THIS INDICATION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO MANUFACTURING DEVIATIONS OR ANOMALIES. 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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THIS 2006/2009-CONSTRUCT FAILED 2012 BECAUSE OF BREAKAGE BETWEEN DIAPHYSIS AND EPIPHYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CTD HUM EPI.42.2 SHOULDER IMPLANT KWS DEPUY FRANCE 2524826

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention