BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY FEMORAL STEM

    MDR report key: 3850022 · Received June 4, 2014

    Report

    Report Number
    1818910-2014-20211
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    July 8, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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

    SALES REP REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. UPDATE REC¿D 5/14/2014 - MEDICAL RECORDS RECEIVED. HIP SIDE IDENTIFIED. PATIENT REVISED TO ADDRESS ELEVATED METAL ION LEVELS, FLUID COLLECTION AND METALLOSIS. UPON REVISION, A SMALL AMOUNT OF CORROSION ON THE TRUNNION WAS NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 06/04/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326665 UNKNOWN DEPUY FEMORAL STEM HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. - 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR