BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 12778712 · Received November 9, 2021

    Report

    Report Number
    3005180920-2021-00871
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 OCTOBER 2021: LOT 1910491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL INFORMATION INVOLVED: GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L (K140826) LOT. 2000503. BATCH REVIEW PERFORMED ON 13 OCTOBER 2021. LOT 2000503: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2020. EXPIRATION DATE: 2025-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS. THE CAUSE OF THE LOOSE IMPLANTS IS UNKNOWN. THE SURGEON REVISED THE INSERT, FEMUR, AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675592 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1203L 1910491 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention