BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION - REVISION TIBIAL TRAY SIZE 2 RIGHT - FINISHING

    MDR report key: 19163666 · Received April 23, 2024

    Report

    Report Number
    3005180920-2024-00233
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819353
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 MARCH 2024. LOT 2000788: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2020. EXPIRATION DATE: 2025-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT. BATCH REVIEW PERFORMED ON 28 MARCH 2024 ON GMK-REVISION 02.07.0217SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 17 MM (K103170) LOT. 189527. LOT 189527: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2019. EXPIRATION DATE: 2024-02-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2022,THE PATIENT CAME IN REPORTING PAIN DUE TO A TIBIAL PLATEAU FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING TIBIAL PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381496 GMK-REVISION - REVISION TIBIAL TRAY SIZE 2 RIGHT - FINISHING KNEE REVISION TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2000788 07630030819353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention