BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25268614 · Received May 25, 2026

    Report

    Report Number
    3005180920-2026-00490
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 25, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707503
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MAY 2026 GMK-SPHERIKA 02.12.0411CRR GMK SPHERE CR TIBIAL INSERT S4R 11MM (K181635) LOT 2243302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2023. EXPIRATION DATE: 10-JAN-2028. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HISTORY WAS AS FOLLOWS: (B)(6) 2024: THE PATIENT PRESENTED WITH A PAINFUL SYNDROME ON THE ANTERIOR ASPECT OF THE RIGHT PROSTHETIC KNEE. (B)(6) 2024: A SECONDARY RESURFACING OF THE PATELLA WAS PERFORMED. (B)(6) 2026: SA SURGICAL DEBRIDEMENT OF THE INNER EDGE OF THE PATELLA WAS PERFORMED. (B)(6) 2026: THE PATIENT DEVELOPED AN ACUTE PERIPROSTHETIC SEPSIS WITH THE PRESENCE OF CITROBACTER FREUNDII; DURING THIS PROCEDURE, ONLY THE INSERT WAS REVISED. (B)(6) 2026: ANTIBIOTIC PRESCRIPTION (INFECTION TREATMENT) WITH NO REVISED PRODUCTS WE ARE WAITING FOR OUTCOMEE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355382 GMK SPHERE TOTAL KNEE SYSTEM GMK SPHERE CR TIBIAL INSERT S4R 11MM JWH MEDACTA INTERNATIONAL SA 02.12.0411CRR 2243302 07630040707503

    Patients

    Seq Age Sex Outcome Treatment
    1