BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT DUOFIX TAP SZ9 HI OFF

    MDR report key: 3022884 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-04368
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    November 21, 2012
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED ELEVATED BLOOD METAL LEVELS AS A RESULT OF THE IMPLANTED ASR HIP. (B)(4) 2012 - SALES REP REPORTED REVISION SURGERY ON RIGHT HIP DUE TO PAIN AND ELEVATED ION LEVELS. X-RAYS AND PART/LOT WERE RECEIVED. (B)(4) 2013 - PATIENT;S OPERATIVE RECORDS WERE RECEIVED. NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION FOR THE LEFT HIP. PART/LOT INFORMATION WAS UPDATED FOR THE LEFT HIP. OPERATIVE RECORDS FOR THE RIGHT HIP INDICATE UPON REVISION YELLOW/METALLIC FLUID,CORROSION, AND PSEUDOTUMOR WERE FOUND IN THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125382 SUMMIT DUOFIX TAP SZ9 HI OFF STEM LPH DEPUY INTERNATIONAL CR9GNA000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male