BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 11806280 · Received May 11, 2021

    Report

    Report Number
    1818910-2021-09996
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 28, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 DHR REVIEW (B)(4) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (8151377).

    Additional Manufacturer Narrative · 1

    (B)(4). DMF# 13704 TRADE NAME GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE DOSAGE FORM POWDER STRENGTH 1.0G ACTIVE IN OUR CEMENTS. INITIAL REPORTER OCCUPATION: LAWYER. (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

    PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT DEGENERATIVE JOINT DISEASE. 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 AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE REMOVAL OF MILD OSTEOLYSIS TYPE SOFT TISSUE AND FIBROUS DEBRIS. FEMUR WAS REMOVED WITH MINIMAL BONE LOSS . THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015 DOR: (B)(6) 2021 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703543 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-50-501 8151377 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FB INSRT SZ 7 6MM| ATTUNE PS FEM LT SZ 7 CEM| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FB INSRT SZ 7 6MM| ATTUNE PS FEM LT SZ 7 CEM| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO