MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT - FLEX S5L - 14 MM

Model Number	02.12.0514FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reports knee pain due to swelling and laxity, probably related to strenuous exercise activity.A 14 mm tibial insert is currently in place, and the surgeon intends to replace it.Therefore, the surgeon has requested 15 mm and 16 mm inserts for assessment, in order to determine which one would be most suitable for the patient.The surgeon requested the 15 mm and 16 mm sizes because he did not believe that a standard size increase (17 mm) would be feasible.X-rays from april 2025 demostratedwell-positioned kinematictkr with centrally tracking patella (the patella was not replaced).A mild effusion was observed in the left knee without signs of infection, as well as a slight anterior drawer laxity with the knee in 90 degrees of flexion.No loosening of the components was observed.
Additional Manufacturer Narrative
Batch review performed on 11 november 2025.Gmk-sphere 02.12.0514fl gmk-sphere tibial insert - flex s5l - 14 mm (k121416) lot 1910178: (b)(4) items manufactured and released on 21-jan-2020.Expiration date: 15-dec-2024.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: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Additional Manufacturer Narrative
Batch review performed on 09 february 2026.Gmk-sphere 02.12.0514fl gmk-sphere tibial insert - flex s5l - 14 mm (k121416) lot 1910178: 25 items manufactured and released on 21-jan-2020.Expiration date: 15-dec-2024.No anomalies found related to the problem.To date, 8 items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0510fr gmk-sphere tibial insert - flex s5r - 10 mm (k121416) lot 2244444: 50 items manufactured and released on 06-feb-2023.Expiration date: 17-jan-2028.No anomalies found related to the problem.To date, 43 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 2 years and 10 months from the primary, the patient reports knee pain due to swelling and laxity, probably related to strenuous exercise activity.It was a bilateral instability, so the surgeon revised the inserts in both knees (left knee from 14 mm to 16 mm; right knee from 10 mm to 11 mm and scar tissue removal).The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT - FLEX S5L - 14 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23615334
• Report Number: 3005180920-2025-01171
• Device Sequence Number: 8969097
• Product Code: JWH
• UDI-Device Identifier: 07630030826818
• UDI-Public: 07630030826818
• Combination Product (Y/N): N
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2024
• Device Model Number: 02.12.0514FL
• Device Lot Number: 1910178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown