BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK 3D METAL TIBIAL TRAY

    MDR report key: 22477460 · Received July 11, 2025

    Report

    Report Number
    3005180920-2025-00655
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 11, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345710802
    PMA / PMN Number
    K221850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 JUNE 2025. GMK-SPHERIKA 02.12.3D02R GMK 3DMETAL TIBIAL TRAY SIZE 2R (K221850) LOT. 2316458 LOT 2316458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25/10/2023. EXPIRATION DATE: 09/10/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT: GMK-SPHERIKA 02.12.E0210FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM (K202022) LOT. 2412079 LOT 2412079: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28/05/2024. EXPIRATION DATE: 13/05/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA163R GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S3R (K223548) LOT. 2345362 LOT 2345362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17/06/2024. EXPIRATION DATE: 28/05/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: THE REPORTED CAUSE WAS NICKEL SENSITIVITY WITH NO ALLEGED DEVICE DEFICIENCY OR CONTRIBUTING FACTOR, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS IN THE KNEE DUE TO A NICKEL SENSITIVITY. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS TO SENSITIN COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT BROUGHT UP NICKEL SENSITIVITY TO THE DOCTOR BEFORE PRIMARY BUT THE SURGEON WAS NOT CONCERNED. TURNED OUT PATIENT DID HAVE NICKEL SENSITIVITY AND HAD TO HAVE ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872572 GMK 3D METAL TIBIAL TRAY GMK 3DMETAL TIBIAL TRAY SIZE 2R JWH MEDACTA INTERNATIONAL SA 02.12.3D02R 2316458 07630345710802

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention