BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21251765 · Received January 28, 2025

    Report

    Report Number
    3005180920-2025-00011
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 28, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261716
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-JANUARY-2024: LOT: 2212715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-09-2022. EXPIRATION DATE: 2027-08-28. 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.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS FROM 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
    1550331 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/20 MM L E-CROSS LOT. JWH MEDACTA INTERNATIONAL SA 02.12.E0320FL 2212715 07630971261716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention