BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21503346 · Received March 3, 2025

    Report

    Report Number
    3005180920-2025-00147
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    February 7, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825941
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 FEBR 2025: LOT 2101660: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2021. EXPIRATION DATE: 2021-03-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330641 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/10 MM R JWH MEDACTA INTERNATIONAL SA 02.12.0110FR 2101660 07630030825941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention