BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 32MM +1

    MDR report key: 3241343 · Received July 22, 2013

    Report

    Report Number
    1818910-2013-21831
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 12, 2013
    Manufacturer
    9616671 DEPUY IRELAND
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. ADDITIONALLY, DISTRIBUTION RESEARCH INDICATES THAT SEVERAL PIECES FROM THE REPORTED LOTS HAVE BEEN DELIVERED, AND, AS NO ADDITIONAL REPORTS HAVE BEEN RECEIVED, CAN BE REASONABLY ASSUMED IMPLANTED WITHOUT ISSUE. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    UPDATE (B)(4) 2013 PRODUCT/LOT INFORMATION ADDED. REVISED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341740 DELTA CER HEAD 12/14 32MM +1 HEAD BALL LZO 9616671 DEPUY IRELAND 3605743

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR