BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 3200322 · Received July 1, 2013

    Report

    Report Number
    1818910-2013-20261
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE ASR RIGHT HIP IMPLANT CAUSED PAINFUL AND PERMANENT INJURIES IN THE PATIENT. LITIGATION FURTHER ALLEGES THAT THE PATIENT EXPERIENCED EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN AND HIGH ION LEVELS. DOR: (B)(6) 2012. UPDATE: ((B)(6) 2012) - PATIENT FACT SHEET WAS RECEIVED. THE SIDE HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. (LEFT SIDE). UPDATE: (B)(6) 2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT UPON REVISION CLOUDY FLUID, INFLAMMATION, GRAY FIBRINOUS MATERIAL, AND LITTLE CORROSION WAS FOUND IN THE JOINT SPACE. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT AND THE COMPLAINT RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300440 ADAPTER SLEEVES 12/14 +5 SLEEVE KWA DEPUY INTL., LTD. - 8010379 3014977

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR