BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT DUOFIX TAP SZ5 STD OFF

    MDR report key: 3850043 · Received June 4, 2014

    Report

    Report Number
    1818910-2014-20221
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    March 18, 2014
    Report Date
    July 10, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 ALLEGES PAIN AND ELEVATED METAL ION LEVELS. UPDATE REC¿D 04/02/2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS CUP LOOSENING. THIS COMPLAINT WAS UPDATED ON: 04/24/2014. UPDATE REC¿D 5/14/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS METALLOSIS. UPON REVISION, CORROSIVE DEBRIS SUGGESTING TRUNNIONOSIS WAS NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 06/04/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326188 SUMMIT DUOFIX TAP SZ5 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. - 1818910 B2WE51000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR