BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23669517 · Received November 28, 2025

    Report

    Report Number
    3005180920-2025-01213
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 28, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262249
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2025. GMK-SPHERIKA 02.12.E0610FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6R - 10MM (K202022) LOT 2416212: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2024. EXPIRATION DATE: 26-JUL-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.KA07R GMK SPHERIKA FEMORAL COMPONENT S7R CEMENTED (K211004) LOT 2415362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28/10/2024. EXPIRATION DATE: 13/10/2029. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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 ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AS A RESULT OF TWISTING HIS KNEEGETTING OUT OF A CAR. THE SURGEON REVISED THE FEMUR AND INSERT (FROM 10 MM TO 20 MM) TO A GMK-REVISION FEMUR AND SEMICONSTRAINED INSERT.THERE WAS NO LIGAMENT ISSUE.THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266289 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6R - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0610FR 2416212 07630971262249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention