BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM STM STD 36+12L 13X18

    MDR report key: 2772283 · Received October 4, 2012

    Report

    Report Number
    1818910-2012-23186
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    November 10, 2011
    Report Date
    October 2, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    LPH
    PMA / PMN Number
    K851422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 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

    PATIENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. IT WAS NOTED THAT THERE WAS LARGE AMOUNTS OF MILKY WHITE LIQUID AND BLACK TISSUE FOUND IN THE HIP. (B)(6) 2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. (B)(6) 2012 - PATIENT OPERATIVE NOTES RECEIVED. IT WAS NOTED THE PATIENT HAD METALLOSIS, CLOUDY, OPAQUE, NEARLY WHITE FLUID WITH DEBRIS, ELEVATED CHROME-COBALT LEVELS, PSEUDOTUMOROUS-TYPE TISSUE, SIGNIFICANT CORROSION OF PRODUCTS AT THE INFERIOR ASPECT OF THE TRUNNION OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM STD 36+12L 13X18 FEMORAL STEM LPH DEPUY IRELAND 2381214

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR