BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23477192 · Received November 5, 2025

    Report

    Report Number
    3005180920-2025-01072
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 15, 2025
    Report Date
    December 1, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262126
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH REVIEW HAS BEEN CORRECTED. BATCH REVIEW PERFORMED ON 24 OCTOBER 2025 LOT 2243426: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2023. EXPIRATION DATE: 04-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.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 OCTOBER 2025 GMK-SPHERIKA 02.12. E0412FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 12MM LOT: 2407635: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2024. EXPIRATION DATE:14-APR-2029. 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

    AT ABOUT 1 YEAR 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491513 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 13MM JWH MEDACTA INTERNATIONAL SA 02.12.E0513FR 2243426 07630971262126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention