BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22345491 · Received June 27, 2025

    Report

    Report Number
    3005180920-2025-00610
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261563
    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 16 JUNE 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12/04/2024. EXPIRATION DATE: 19/93/2029. 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: 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

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE POLY (FROM 11 TO 17MM) TO GIVE STABILITY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REVISION WAS NOT RELATED TO MEDACTA PRODUCTS/EFFECTIVENESS. THE PATIENT PRESENTED WITH POST OP PAIN AND INSTABILITY AND THE SURGEON SCHEDULED THIS AS AN EXPLORATORY SURGERY AND DECIDED TO EXCHANGE THE POLY WHILE HE WAS IN THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939428 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 11MM JWH MEDACTA INTERNATIONAL SA 02.12.E0311FR 2405545 07630971261563

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention