BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 3172682 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19027
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    August 17, 2007
    Report Date
    May 22, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    MEDICAL RECORDS WERE RECEIVED FROM LEGAL, RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274151 DELTA CER HEAD 12/14 36MM +1.5 FEMORAL HEAD LZO DEPUY INTL., LTD. ¿ REG. # 8010379 1878914

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention