BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM STD 36+12L 17X22

    MDR report key: 2834302 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-27433
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 27, 2011
    Report Date
    October 30, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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

    PATIENT WAS REVISED DUE TO PAIN, FLUID AND METALLOSIS. IT WAS NOTED THAT THE COBALT LEVEL WAS 3.6 AND THE CHROMIUM LEVEL WAS 1.9. LITIGATION PAPERS RECEIVED (B)(4) 2012 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED (PART/LOT) INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS RECEIVED. NOTED WERE FINE LINEAR SCRATCHES, WHICH WERE MULTIDIRECTIONAL, ON THE FEMORAL HEAD. THE TAPER HAD CORROSIVE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM STD 36+12L 17X22 FEMORAL STEM MRA DEPUY RAYNHAM 2844684

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention