BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CERAMIC HEAD

    MDR report key: 3163153 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18633
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    July 6, 2011
    Report Date
    May 17, 2013
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED AGAIN DUE TO RECURRENT DISLOCATION. INTRAOPERATIVE IT WAS DISCOVERED THAT THE PATIENT HAS EXTREMELY POOR ABDUCTOR TONE WITH VIRTUALLY NO CONTRACTILITY OF THE ABDUCTORS WHEN TOUCHED WITH THE BOVIE. DOI: (B)(6) 2011 - DOR: (B)(6) 2011 (LEFT HIP). UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES HIP FAILURE. THE MDR DECISION HAS BEEN REVERSED AND THE LINER AND HEAD ARE NOW BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263920 UNKNOWN DEPUY CERAMIC HEAD TOTAL HIP REPLACEMENT KXA DEPUY IRELAND ¿ REG. # 9616671 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention