BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-LOCK BPS SZ 8 STD OFFSET

    MDR report key: 2801168 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-23672
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    April 25, 2012
    Report Date
    October 18, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    PMA / PMN Number
    K073570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. 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

    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 PAPERS ALLEGE: PAIN AND SUFFERING, AND ADDITIONAL POTENTIAL UNFORESEEN SURGERIES, METALLOSIS, LOSS OF PERSONAL DIGNITY AND SIGNIFICANT AND CHRONIC PAIN. PATIENT RESIDENCE: (B)(6). (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO ELEVATION ION LEVELS. DOR: (B)(6) 2012. (B)(4) 2012 - OPERATIVE NOTES WERE RECEIVED. IT WAS NOTED THERE WAS FLUID IN THE JOINT, A PSEUDOCAPSULE IN THE DEEP HIP, EROSION AROUND THE ACETABULAR CUP, AND CORROSION OF THE FEMORAL NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-LOCK BPS SZ 8 STD OFFSET FEMORAL STEM KWA DEPUY WARSAW DH8CA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR