BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM*STM ST,36+8L NK,18X13X160

    MDR report key: 3233092 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21517
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    DEPUY (IRELAND) - 9616671
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR 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 TO ADDRESS PAIN. **UPDATE** (B)(4) 2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE** MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES INCREASED COBALT AND CHROME LEVELS, CYST FORMATION, YELLOWISH FLUID, HARD PSEUDOTUMOR, SCRATCHES ON THE FEMORAL HEAD AND ACETABULAR COMPONENT, SIGNIFICANT EVIDENCE OF GALVANIC ROTATION AND GALVANIC CORROSION. ADAPTER SLEEVE, STEM, AND STEM SLEEVE ADDED TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333403 SROM*STM ST,36+8L NK,18X13X160 FEMORAL STEM JDI DEPUY (IRELAND) - 9616671 2245158

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR