BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22620673 · Received July 25, 2025

    Report

    Report Number
    3005180920-2025-00716
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2025. LOT. 2011125: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2020. EXPIRATION DATE: 01-DEC-2025. 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. ROOT CAUSE: THE SURGEON REVISED LINER HEIGHT, 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.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (10 TO 12 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178001 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S4L - 10 MM JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 2011125 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention