BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 10427049 · Received August 19, 2020

    Report

    Report Number
    1818910-2020-18406
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 7, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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:  DETAILS FOR GENTAMICIN COMPONENT OF COMBINATION PRODUCT: 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 · 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: DEVICE HISTORY REVIEWED: 2 UNRELATED NON CONFORMANCES ON THIS BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 3 ADDITIONAL REPORTS; 2 RELATED TO IMPLANT LOOSENING AND 1 UNRELATED. TOTAL FOR LOT NUMBER: 3 (B)(4). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 116, BY PRODUCT FAMILY: 182 (63X SMARTSET GHV, 119X SMARTSET GMV).

    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

    THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. TIBIAL BASE, INSERT AND PATELLA WERE REPLACED. DOI: (B)(6) 2015, DOR: (B)(6) 2020, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893300 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-50-501 8159607 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ATTUNE FB TIB BASE SZ 4 CEM| ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS FB INSRT SZ 4 8MM| ATTUNE PS FEM LT SZ 4 NAR CEM| SMARTSET GMV 40G US EO