BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 11463869 · Received March 11, 2021

    Report

    Report Number
    1818910-2021-04955
    Event Type
    Injury
    Date Received
    March 11, 2021
    Date of Event
    May 7, 2019
    Report Date
    February 26, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174288
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

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

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. DMF# - (B)(4), TRADE NAME GENTAMICIN SULPHATE, ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE, DOSAGE FORM - POWDER, STRENGTH 1.0G ACTIVE IN OUR CEMENTS. 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 RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT VALGUS OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, TIBIAL TRAY MIGRATION, MISPOSITIONING, AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND DEPUY CEMENT X 2. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358012 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 5450-35-500 8163564 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS FEM LT SZ 5 CEM| ATTUNE PS RP INSRT SZ5 6MM| ATTUNE RP TIB BASE SZ 5 CEM| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G