BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM STM ST,36+6L NK,11X16X150

    MDR report key: 2792724 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-22651
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    August 8, 2011
    Report Date
    October 10, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    LPH
    PMA / PMN Number
    K954935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 TO ADDRESS PAIN. **UPDATE** (B)(4) 2012 - REVISION OPERATIVE REPORT WAS RECEIVED. THE PATIENT WAS REVISED TO ADDRESS PSEUDOTUMOR, CYST, SOFT TISSUE MASS, AND CORROSION WAS NOTED AT THE NECK TRUNNION TAPER LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM ST,36+6L NK,11X16X150 TOTAL HIP REPLACEMENT LPH DEPUY IRELAND 2769481

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR