MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM

Model Number	02.12.E0511FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 1 year and 2 months from primary surgery, the patient presented with anterior knee pain and instability of unknown cause.During revision surgery, the surgeon resurfaced the patient`s natural patella using a competitor patella and upsized the liner to improve joint stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 dec 2025.Lot 2307926: (b)(4) items manufactured and released on 03 july 2023.Expiration date: 14 june 2028.No anomalies found related to the problem.To date, 45 items of the same lot have been sold, with no similar reported event during the period of review.Root cause: the surgeon revised the liner height and resurfaced the patella, which is a common practice to restore joint stability and solve pain.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM
• 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: 24031943
• Report Number: 3005180920-2026-00020
• Device Sequence Number: 10276998
• Product Code: JWH
• UDI-Device Identifier: 07630971262041
• UDI-Public: 07630971262041
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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 Model Number: 02.12.E0511FR
• Device Lot Number: 2307926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White