BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 32MM +1

    MDR report key: 7012828 · Received November 9, 2017

    Report

    Report Number
    1818910-2017-28383
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    UDI-DI
    10603295033431
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: 8446807. WORK ORDER (B)(4) WAS MANUFACTURED ON 06 JANUARY 2017. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. COFC REVIEW FOR (B)(4): MET SPECIFICATION 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

    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

    THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791712 DELTA CER HEAD 12/14 32MM +1 HIP FEMORAL HEAD LZO DEPUY IRELAND - 9616671 8446807 10603295033431

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention