BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY STEM

    MDR report key: 2983564 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-02261
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    October 9, 2012
    Report Date
    October 24, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION CORROSION WAS FOUND AROUND THE SLEEVE NECK JUNCTION. THE STEM AND SLEEVE WERE ADDED TO THE COMPLAINT, AND THE COMPLAINT RE-OPENED. DOR: (B)(6) 2012. **UPDATE** ((B)(4) 2013) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. 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.

    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

    LITIGATION ALLEGES PATIENT HAD PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT. (B)(6) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION CORROSION WAS FOUND AROUND THE SLEEVE NECK JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85757 UNKNOWN DEPUY STEM STEM KWA DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR