BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

    MDR report key: 7876587 · Received September 14, 2018

    Report

    Report Number
    3005180920-2018-00688
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 22, 2018
    Report Date
    September 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817656
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 SEPTEMBER 2018: LOT 122367: 25 ITEMS MANUFACTURED AND RELEASED ON 19 DECEMBER 2012. EXPIRATION DATE: 2017-08-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER IMPLANT INITIALLY SUSPECTED TO BE LOOSE, BUT NOT CONFIRMED DURING REVISION SO NOT EXPLANTED: GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L (K123721), LOT 122880: 40 ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 38 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON WAS REVISING THE PATIENT ON (B)(6) 2108 DUE TO SUSPECTED TIBIAL LOOSENING ABOUT 3 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE PATIENT ON THE PLANNED DATE BUT THE LOOSENING WAS NOT CONFIRMED, SO THE REASON FOR REVISION WAS GENERIC PAIN AND THE SURGEON REVISED THE JOINT IMPLANTING A NEW INSERT SEMICONSTRAINED 12MM S4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717324 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0410SCF 122367 07630030817656

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention