BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 9490290 · Received December 18, 2019

    Report

    Report Number
    1818910-2019-123821
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    March 19, 2018
    Report Date
    November 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K023012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

    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. (B)(4).

    Description of Event or Problem · 1

    DER STATES THAT THE PATIENT HAD LTK PERFORMED ON (B)(6) 2015. AN ATTUNE CEMENTED RP/PS WAS USED. ON (B)(6) 2016 THE PATIENT WAS REVISED. THE POLY INSERT WAS EXCHANGED TO A THICKER STYLE. ON (B)(6) 2018 THE PATIENT WAS BROUGHT TO THE OR FOR PAIN. THE TIBIAL TRAY AND POLY INSERT WERE EXCHANGED. A STEMMED ATTUNE TIBIAL TRAY WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285392 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3092-040 7957561 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM LT SZ 6 CEM