BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3771587 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17461
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    DEPUY IRELAND
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. LATE LETTER ATTACHED FOR PREVIOUS MEDWATCH. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 PAIN, METALLOSIS, TISSUE AND FLUID FORMATION, DIFFICULTY WALKING AND ELEVATED METAL ION LEVELS. UPDATE REC'D (B)(4) 2014 - MEDICAL RECORDS RECEIVED. UPON REVISION METAL DARK STAINING, BLACK-STAINED TISSUE WITHIN THE JOINT, AND CORROSION WERE FOUND. THE SLEEVE, STEM SLEEVE, AND STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249844 SROM STM ST,36+6L NK,11X16X150 HIP FEMORAL STEM/SLEEVE LPH DEPUY IRELAND 1953524

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other