BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 9440172 · Received December 9, 2019

    Report

    Report Number
    1818910-2019-121808
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    July 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    UDI-DI
    10603295174288
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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). 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. DEVICE HISTORY LOT ==> 8163564. DEVICE HISTORY REVIEW ==> A PREVIOUS DEVICE HISTORY RECORD (DHR) REVIEW (B)(4) REVEALED NO NON-CONFORMANCES AGAINST THE REPORTED LOT NUMBER (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

    ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 1. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS GROSSLY LOOSE AND NOTED A LARGE PROXIMAL TIBIAL DEFECT. HE NOTED A FEMORAL COMPONENT WAS REMOVED AFTER DISRUPTING THE INTERFACE WITH OSTEOTOMES. THE SURGEON INDICATED THE PATELLA TRACKED CENTRALLY SO WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND COMPETITOR BONE CEMENT, THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2019. (RT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233874 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 8163564 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention