BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 23001780 · Received September 9, 2025

    Report

    Report Number
    3005180920-2025-00874
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    April 25, 2025
    Report Date
    September 9, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345716286
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 AUGUST 2025: GMK-SPHERIKA 02.12.KA16R FEMORAL COMPONENT SPHERIKA CEMENTED S6+R LOT. 2401780 (K211004) LOT 2401780: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APRIL-2024. EXPIRATION DATE: 2029-04-10. 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. ADDITIONAL IMPLANTS REVISED, BATCH REVIEW PERFORMED ON 25 AUGUST 2025: GMK-SPHERIKA 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R (K090988) LOT 2412638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2024. EXPIRATION DATE: 2029-07-28. 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-SPHERIKA 02.12.0610FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R (K121416) LOT 2108933: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-09-02. 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. CONCLUSION: THE DEVELOPMENT OF STIFFNESS OF THE JOINT IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, SURGEON DECIDED TO TREAT THE PATIENT WITH KNEE MANIPULATION. 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 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS. OPEN ARTHROLYSIS HAS BEEN PERFORMED IN ORDER TO RESTORE THE JOINT MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068873 GMK TOTAL KNEE SYSTEM FEMORAL COMPONENT SPHERIKA CEMENTED S6+R JWH MEDACTA INTERNATIONAL SA 02.12.KA16R 2401780 07630345716286

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention