BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 10778528 · Received November 3, 2020

    Report

    Report Number
    1818910-2020-23844
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    March 5, 2020
    Report Date
    October 19, 2020
    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
    PA, 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 · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: DMF# - 13704, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. ON (B)(6) 2020, THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO LEFT TOTAL KNEE TIBIAL BASEPLATE LOOSENING. IT IS INDICATED THAT UPON ENTERING THE JOINT, TISSUE WAS SENT FOR FROZEN SECTION WHICH REVEALED 2 NEUTROPHILS PER HIGH-POWERED FIELD. THIS IS INDICATIVE OF SEPTIC (INFECTION) LOOSENING. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE, INTERFACE NOT PROVIDED. TIBIAL BASEPLATE, INSERT, FEMORAL COMPONENT AND PATELLA WERE REVISED. THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY FOR THE INSERT, FEMORAL COMPONENT OR PATELLA. DEPUY REVISION PRODUCTS AND COMPETITOR CEMENT (HERAEUS MEDICAL) UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2015. DOR: (B)(6) 2020. LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243103 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 55 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM LT SZ 5 NAR CEM| ATTUNE PS RP INSRT SZ5 5MM| ATTUNE RP TIB BASE SZ 3 CEM| SMARTSET GMV 40G US EO| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM LT SZ 5 NAR CEM| ATTUNE PS RP INSRT SZ5 5MM| ATTUNE RP TIB BASE SZ 3 CEM| SMARTSET GMV 40G US EO