BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +8

    MDR report key: 3052079 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-06574
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. (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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED REGARDING THE REPORTED STEM CORROSION. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PATIENTS OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS A PAINFUL HIP WITH ASSOCIATED SYNOVITIS, ELEVATED METAL ION LEVELS, CLUNKING, AND CATCHING. UPON REVISION DARK STAINED TISSUE AND CORROSION AND THREADING AROUND THE TRUNNION WERE FOUND. THE SOCKET HAD 20-30% INGROWTH AND WAS NOT LOOSE. THE STEM AND SLEEVE WERE ADDED TO THE COMPLAINT. (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154633 ADAPTER SLEEVES 12/14 +8 SLEEVE KWA DEPUY INTERNATIONAL 2422567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention