BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 3689880 · Received March 20, 2014

    Report

    Report Number
    1818910-2014-14795
    Event Type
    Injury
    Date Received
    March 20, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 25, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION DISCOVERED THAT THIS MEDWATCH IS A DUPLICATE OF 181890-2014-14729, THEREFORE THIS MEDWATCH IS BEING REJECTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REVISED BECAUSE OF INFECTION. DOI UNK DOR (B)(6) 2014. 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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

    THE PATIENT WAS REVISED BECAUSE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167382 DELTA CER HEAD 12/14 36MM +1.5 HIP FEMORAL HEAD LZO DEPUY IRELAND 9616671 3425644

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention