BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 3R

    MDR report key: 16327117 · Received February 8, 2023

    Report

    Report Number
    3005180920-2023-00068
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 8, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040721950
    PMA / PMN Number
    K210010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JANUARY 2023. LOT 2001241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JULY-2020. EXPIRATION DATE: 2025-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON 25 JANUARY 2023 ON GMK-HINGE 02.09.2704R GMK-HINGE FEMORAL COMPONENT SIZE 4 R - TINBN COATED (K210010) LOT. 2001236 LOT 2001236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JULY-2020. EXPIRATION DATE: 2025-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 25 JANUARY 2023 ON GMK-HINGE 02.09.0317H FIXED TIBIAL INSERT SIZE 3/17MM (K130299) LOT. 181582 LOT 181582: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS IN THE KNEE AND THE CAUSE OF THE STIFFNESS IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229057 GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 3R KNEE TINBN COATED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.09.4803R 2001241 07630040721950

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention