BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM

    MDR report key: 9769048 · Received February 28, 2020

    Report

    Report Number
    3005180920-2020-00106
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817748
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 FEBRUARY 2020: LOT 168565: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-MAR-2017. EXPIRATION DATE: 2020-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. OTHER DEVICES INVOLVED IN THE EVENT: GMK-PRIMARY 02.07.2004L FEMUR STD CEMENTED SIZE 4 L LOT. 113976 (K090988). BATCH REVIEW PERFORMED ON 25 FEBRUARY 2020: LOT 113976: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DIC-2011. EXPIRATION DATE: 2016-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. GMK-PRIMARY 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L LOT. 114497 (K090988). BATCH REVIEW PERFORMED ON 25 FEBRUARY 2020: LOT 114497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 LOT. 120696 (K090988). BATCH REVIEW PERFORMED ON 25 FEBRUARY 2020: LOT 120696: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2012. EXPIRATION DATE: 2017-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    TWO YEARS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN REPORTING PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED ALL THE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234517 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM TIBIAL INSERT PS FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0412PSF 07630030817748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention