BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY STEM

    MDR report key: 3211735 · Received July 8, 2013

    Report

    Report Number
    1818910-2013-20672
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION 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.

    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

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS A FAILED ACETABULAR COMPONENT OF THEIR LEFT TOTAL HIP. UPON REVISION TEA COLORED FLUID AND CORROSION WERE FOUND IN THE HIP JOINT. THE ACETABULAR COMPONENT WAS FOUND TO HAVE ONLY FIBROUS INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311000 UNKNOWN DEPUY STEM STEM KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR