BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 4380998 · Received January 5, 2015

    Report

    Report Number
    1818910-2015-10107
    Event Type
    Injury
    Date Received
    January 5, 2015
    Date of Event
    December 9, 2014
    Report Date
    December 9, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PROVIDED 1823106 LOT CODE IDENTIFIED NO OTHER REPORTS. THE SEARCH WAS NOT POSSIBLE AGAINST THE REMAINING DEVICES AS THE NECESSARY PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CANNOT DRAW ANY CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4416 ARTICULEZE M HEAD 36MM +5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD 8010379 1823106

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention