BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 24494907 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00167
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    July 28, 2022
    Report Date
    March 3, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2026. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIX CEMENTED S.5R (K090988) LOT 2116015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MARCH-2022. EXPIRATION DATE: 2027-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0005R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 5R (K121416) LOT 2117575: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2022. EXPIRATION DATE: 2027-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0512FR GMK-SPHERE TIBIAL INSERT - FLEX S5R - 12 MM (K121416) LOT 2011064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2020. EXPIRATION DATE: 2025-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: THE DEVELOPMENT OF STIFFNESS OF THE JOINT IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA AND THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING TIGHTNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED FEMORAL COMPONENT, TIBIAL TRAY AND INSERT (SIZE 5 TO SIZE 4). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450403 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.5R JWH MEDACTA INTERNATIONAL SA 02.07.1205R 2116015 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention