BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 STD OFF

    MDR report key: 2232107 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17055
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    May 19, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    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 FINDS NO OTHER REPORTS OF CORROSION 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT MAY UNDERGO REVISION SURGERY IN THE FUTURE IF INDICATED BY HIS DOCTOR FOR DISCOMFORT, HIP PAIN AND LOOSENING. UPDATE - (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT THERE WERE CORROSIVE CHANGES SEEN ON THE TRUNNION. IT IS ADDITIONALLY NOTED THAT THERE WAS A CYST POSTEROINFERIORLY WHICH WAS ABOUT 1 CM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT POR TAPER SZ6 STD OFF FEMORAL HIP STEM LPH DEPUY INTERNATIONAL AV2BD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention