BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK 3D METAL TIBIAL TRAY

    MDR report key: 23167332 · Received September 29, 2025

    Report

    Report Number
    3005180920-2025-00962
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K221850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 SEPT 2025. GMK-SPHERIKA 02.12.3D03L GMK 3DMETAL TIBIAL TRAY SIZE 3L (K221850) LOT: 2433519: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2025. EXPIRATION DATE: 2030-MAY-12. 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 DEVICES ALSO REVISED: BATCH REVIEW PERFORMED ON 15 SEPT 2025. GMK-SPHERIKA 02.12. E0313FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 13MM (K202022) LOT: 2433519: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JAN-2025. EXPIRATION DATE: 2029-DEC-17. 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. KA163L GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S3L (K223548) LOT: 2504217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-APR-2025. EXPIRATION DATE: 2030-APR-01. 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. CONCLUSIONS: THE CAUSE IS REPORTED TO BE RELATED TO THE IMPLANT'S CHOSEN SIZE AT THE PRIMARY SURGERY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT 6 DAYS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN OVERSIZED TIBIA THAT WAS IMPLANTED DURING THE PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA, AND POLY TO A CEMENTED FEMUR, TIBIA AND SMALLER SIZED POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    EVENT DESCRIPTION UPDATE AFTER NEW INFO ON 1 OCTOBER 2025: AT 6 DAYS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN OVERSIZED TIBIA (ABOUT 10 MM) THAT WAS IMPLANTED DURING THE PRIMARY SURGERY. THE SURGEON REVISED THE TIBIA AND POLY TO SMALLER SIZES, AND REVISED THE FEMUR COMPONENT TO A CEMENTED ONE TO GAIN SUFFICIENT ACCESS TO REMOVE THE TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145885 GMK 3D METAL TIBIAL TRAY GMK 3DMETAL TIBIAL TRAY SIZE 3L JWH MEDACTA INTERNATIONAL SA 02.12.3D03L 2504469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention