BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +5.0

    MDR report key: 7043978 · Received November 18, 2017

    Report

    Report Number
    1818910-2017-50049
    Event Type
    Injury
    Date Received
    November 18, 2017
    Date of Event
    October 24, 2017
    Report Date
    October 24, 2017
    Manufacturer
    DEPUY IRELAND 961610
    Product Code
    LZO
    UDI-DI
    10603295033660
    PMA / PMN Number
    K071830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (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 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 HAD COMPLAINED OF PAIN AND WAS CONVINCED BY PHYSIO THAT THE SCREWS WERE RUBBING ON PSOAS MUSCLE SO REQUESTED REMOVAL OF THE CUP SCREWS. PATIENT ALSO HAD ABDUCTOR ISSUES SO A CONSTRAINED LINER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823282 DLT TS CER HD 12/14 36MM +5.0 HIP FEMORAL HEAD LZO DEPUY IRELAND 961610 3411848 10603295033660

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention