BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY FEMORAL STEM

    MDR report key: 3183182 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19557
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 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. 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

    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

    REVISION OPERATIVE REPORT STATES DURING THE REVISION, THE FOLLOWING WAS FOUND: A LARGE FLUID COLLECTION THAT WAS DARK BROWN AND TURBID, MODERATE FRETTING AND CORROSION ON THE STEM TAPER.

    Description of Event or Problem · 1

    REVISION OPERATIVE REPORT STATES DURING THE REVISION, THE FOLLOWING WAS FOUND: A LARGE FLUID COLLECTION THAT WAS DARK BROWN AND TURBID, MODERATE FRETTING AND CORROSION ON THE STEM TAPER. **UPDATE** (B)(4) 2013. LITIGATION PAPERS ALLEGE PAIN, PERMANENT INJURY AND ELEVATED METAL ION LEVELS. **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND DOB. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283584 UNKNOWN DEPUY FEMORAL STEM FEMORAL STEM JDI DEPUY ORTHOPAEDICS, INC. - 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR