BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L

    MDR report key: 14160016 · Received April 20, 2022

    Report

    Report Number
    3005180920-2022-00266
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    July 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819940
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 MARCH 2022: LOT 1910498: 34 ITEMS MANUFACTURED AND RELEASED ON 06-APR-2020. EXPIRATION DATE: 2025-03-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 28 MARCH 2022: GMK-SPHERE 02.12.0026L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ L (K140826) LOT 2000512: 49 ITEMS MANUFACTURED AND RELEASED ON 29-APR-2020. EXPIRATION DATE: 2025-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 34 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0613FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM L (K140826) LOT 176163: 25 ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2018. EXPIRATION DATE: 2023-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    ON THE 7 JUNE 2022 MEDACTA USA INFORMED MEDACTA INTERNATIONAL THAT ON THE (B)(6) 2022 THE SPACER WAS REMOVED AND PERMANENT IMPLANT INSERTED IN THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 MONTHS FROM PRIMARY SURGERY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 MONTHS FROM PRIMARY SURGERY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON THE (B)(6) 2022 THE SPACER WAS REMOVED AND PERMANENT IMPLANT INSERTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2749576 GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1206L 1910498 07630030819940

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention