BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23579961 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01135
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261648
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 NOVEMBER 2025: GMK-SPHERIKA 02.12.E0313FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 13MM (K202022) LOT 2319578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2023. EXPIRATION DATE: 2028-JUL-25. 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 02.15.E029 MOTO PATELLA E-CROSS D 29 (K213071) LOT 2418507: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2024. EXPIRATION DATE: 2029-JUL-30. 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 SURGEON REVISED POLY HEIGHT AND UPSIZED THE PATELLA WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    B5 UPDATED.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY KNEE SURGERY USING A COMPETITOR PRODUCT. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA IMPLANTS. ON, (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN AND FEELING UNSTABLE AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. UPON REMOVING THE POLY, THE SURGEON REMOVED MULTIPLE BONE SPURS AND CEMENT CHUNKS.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY KNEE SURGERY USING A COMPETITOR PRODUCT. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA IMPLANTS. ON, (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN AND FEELING UNSTABLE AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY AND PATELLA, IMPLANTING THICKER IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. UPON REMOVING THE POLY, THE SURGEON REMOVED MULTIPLE OSTEOPHYTES DUE TO PATIENT PATHOLOGY AND CEMENT CHUNKS (COMPETITOR CEMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103375 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 13MM JWH MEDACTA INTERNATIONAL SA 02.12.E0313FR 2319578 07630971261648

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention