BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 4851126 · Received June 17, 2015

    Report

    Report Number
    1818910-2015-23828
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    MRA
    PMA / PMN Number
    PP070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393721 DELTA CER HEAD 12/14 36MM +1.5 HIP FEMORAL HEAD MRA DEPUY (IRELAND) 9616671 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention