BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT DUOFIX TAP SZ4 STD OFF

    MDR report key: 3780749 · Received April 30, 2014

    Report

    Report Number
    1818910-2014-17748
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    February 24, 2014
    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
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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. BASED ON THE INABILITY TO FIND ANY OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE, IT IS NOT UNREASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING, INSPECTION OR STERILIZATION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    SALES REP REPORTED REVISION SURGERY. DOI PULLED FROM INVOICE. PATIENT HAS BEEN REVISED TO ADDRESS PAIN. UPDATE: (B)(4) 2014 - LITIGATION RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS AND DURING REVISION REVEALED A PSEUDOTUMOR, CORROSION, AND METALLOSIS. THE FEMORAL STEM IS 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
    259149 SUMMIT DUOFIX TAP SZ4 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. - 1818910 C4RCC1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR