BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23837359 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01289
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 DECEMBER 2025: GMK-SPHERE 02.12.0510FR GMK-SPHERE TIBIAL INSERT - FLEX S5R - 10 MM (K121416) LOT 176185: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2018. EXPIRATION DATE: 2022-DEC-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 70 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.0036RP RESURFACING PATELLA SIZE 4 (K113571) LOT 180316: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2018. EXPIRATION DATE: 2023-APR-24. 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 CAME IN REPORTING KNEE INFECTION. AT 7 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT AND REMOVED THE PATIENT`S PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275063 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S5R - 10 MM JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 176185 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention