BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY FEMORAL STEM

    MDR report key: 3924492 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23067
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    January 20, 2014
    Report Date
    August 15, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. UPON REVISION, YELLOW FLUID, DARK STAINED TISSUE, CORROSION ON THE TRUNNION, DARK DEBRIS FILLING THE BACK OF THE ACETABULAR CUP, AND MINIMAL BONY INGROWTH INTO THE ACETABULAR CUP WERE NOTED. THE STEM REMAINED IN SITU. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. UPON REVISION, YELLOW FLUID, DARK STAINED TISSUE, CORROSION ON THE TRUNNION, DARK DEBRIS FILLING THE BACK OF THE ACETABULAR CUP, AND MINIMAL BONY INGROWTH INTO THE ACETABULAR CUP WERE NOTED. THE STEM REMAINED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404270 UNKNOWN DEPUY FEMORAL STEM HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. - 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR