BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 28MM +5

    MDR report key: 2820992 · Received November 6, 2012

    Report

    Report Number
    1818910-2012-27488
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LZO
    PMA / PMN Number
    K011533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CER HEAD 12/14 28MM +5 FEMORAL HEAD LZO DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention