BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21354413 · Received February 11, 2025

    Report

    Report Number
    3005180920-2025-00081
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    January 22, 2025
    Report Date
    February 11, 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 29 JANUARY 2025: LOT: 2240038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2022. EXPIRATION DATE: 2027-11-14. 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.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (10 TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708603 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 2240038 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention