BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 3920802 · Received July 8, 2014

    Report

    Report Number
    1818910-2014-23002
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 2, 2013
    Report Date
    June 19, 2014
    Manufacturer
    UNKNOWN
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. IT SHOULD BE NOTED THESE RECORDS WERE RECEIVED THROUGH A PFS FOR EXISTING COMPLAINT. FORMAL LITIGATION HASN¿T BEEN FILED YET, SO THIS COMPLAINT ISN'T LEGAL. PATIENT WAS REVISED FOR INFECTION. A UNKNOWN HEAD AND LINER ARE BEING REPORTED. THE PATIENT HAD A NEW HEAD AND LINER IMPLANTED ON (B)(6) 2013. THE LINER AND HEAD WERE REMOVED FOR INFECTION ON (B)(6) 2013 AND NO NEW IMPLANTS WERE PUT IN ON (B)(6) 2013. THE PATIENT WENT THROUGH 48 HOURS OF ANTIBIOTICS AND REIMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398423 UNKNOWN DEPUY FEMORAL HEAD HIP FEMORAL HEAD KXA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention