BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT POR TAPER SZ7 HI OFF

    MDR report key: 3780830 · Received April 30, 2014

    Report

    Report Number
    1818910-2014-17741
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    June 6, 2013
    Report Date
    June 4, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 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

    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 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, GRINDING, CLICKING, POPPING, INSTABILITY, INFECTION, PERMANENT DISABILITY AND DISFIGUREMENT AND ELEVATED METAL ION LEVELS. UPDATE: (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS FLUID COLLECTION. UPON REVISION METAL STAINED CLOUDY FLUID AND CORROSION WERE FOUND. THE ADAPTER SLEEVE AND FEMORAL HEAD 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
    260693 SUMMIT POR TAPER SZ7 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. - 1818910 C78GN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR