BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22000386 · Received May 12, 2025

    Report

    Report Number
    3005180920-2025-00433
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707343
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2025. LOT 2112391: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-10-20. 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. 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 AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING LATERAL INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER (10 TO 12 MM) FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826722 GMK SPHERE TOTAL KNEE SYSTEM GMK SPHERE CR TIBIAL INSERT SZE 3R 10MM JWH MEDACTA INTERNATIONAL SA 02.12.0310CRR 2112391 07630040707343

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention