BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 11697555 · Received April 20, 2021

    Report

    Report Number
    1818910-2021-08340
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 5, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). 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 WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2016 DOR: (B)(6) 2021 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590395 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 5450-50-501 8151377 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ATTUNE FB TIB BASE SZ 5 CEM.| ATTUNE PS FB INSRT SZ 6 5MM.| SMARTSET GMV 40G US EO.