BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 7051770 · Received November 21, 2017

    Report

    Report Number
    1818910-2017-50133
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 24, 2017
    Report Date
    October 24, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    LOD
    UDI-DI
    10603295174288
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    THE PATIENT HAS A DEPUY SYNTHES LTK. THE PATIENT WAS SCHEDULED TO HAVE THEIR POLYETHYLENE TIBIAL INSERT EXCHANGED TO A THICKER SIZE TO ADDRESS SOME KNEE JOINT LAXITY. THE SURGEON PLANNED TO EXPLORE THE FEMORAL, TIBIAL AND PATELLA COMPONENT INTERFACES TO DETERMINE IF THEY WERE LOOSE. UPON EXPLORATION OF THE TIBIAL TRAY, IT WAS DETERMINED TO BE LOOSE. THE SURGEON ELECTED TO EXTRACT THE WELL FIXED FEMORAL COMPONENT AS WELL AND TO RE-IMPLANT REVISION STYLE COMPONENTS. THE PATELLA COMPONENT WAS ALSO DEEMED TO BE WELL FIXED TO THE HOST BONE AND THEREFORE IT WAS RETAINED. IT WAS ALSO REPORTED THAT THE LOOSENING INTERFACE WAS CEMENT/IMPLANT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828862 SMARTSET GHV GENTAMICIN 40G BONE CEMENT LOD DEPUY INTERNATIONAL LTD. 8010379 3215059 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention