BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT DUOFIX TAP SZ5 STD OFF

    MDR report key: 2801610 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-22655
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 4, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 COMPLAINT 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 ALLEGES THAT PATIENT HAS EXPERIENCED PAIN, WEAKNESS, AND THE IMPLANT GENERATED EXCESSIVE METAL DEBRIS. ***UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. **UPDATE** (B)(4) 2012 - REVISION OPERATIVE REPORT WAS RECEIVED. BROWN FLUID AND CORROSIVE MATERIAL WAS NOTED AFTER THE FEMORAL HEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT DUOFIX TAP SZ5 STD OFF FEMORAL STEM LPH DEPUY WARSAW DF6AP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR