BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 3131766 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-04378
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. IT IS KNOWN 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. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE

    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 PATIENT HAD ACETABULAR CUP DETACHED, DISCONNECTED AND CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM ACETABULUM, CAUSED SEVERE PAIN AND INHIBITED ABILITY TO WALK AFTER ASR HIP IMPLANT. DOI: (B)(6) 2006 (RIGHT HIP). DOR: NONE REPORTED. UPDATE: (B)(6) 2013-SALES REP REPORTED REVISION SURGERY DUE TO ELEVATED CHROMUIM LEVELS OF 3.5, ALVAL, AND OSTEOLYSIS. PART/LOT WERE IDENTIFIED. DOR: (B)(6) 2013 UPDATE: (B)(6) 2013 - PATIENTS REVISION RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION NECROTIC TISSUE, A PARTIALLY INGROWN ACETABULAR COMPONENT, AND CORROSION WERE ALL FOUND IN THE HIP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237028 ADAPTER SLEEVES 12/14 +5 SLEEVE KWA DEPUY INTERNATIONAL 2160170

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR