BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21585876 · Received March 12, 2025

    Report

    Report Number
    3005180920-2025-00187
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862588
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 FEBRUARY 2025: LOT 1902497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUNE-2019. EXPIRATION DATE: 2024-05-27. 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 5 YEARS 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY (11 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175018 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM R JWH MEDACTA INTERNATIONAL SA 02.12.0311FR 1902497 07630030862588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention