MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 20MM

Model Number	02.12.E0320FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary right knee surgery on (b)(6) 2025.On (b)(6) 2025, the patient came in due to pain as a result of a periprosthetic fracture of the proximal tibia and the cause is unknown.The surgeon removed the tibial tray, insert, and extension stem and implanted a new insert, tibial tray, extension stem, and tibial augmented screws.The surgery was completed successfully.Presently, on (b)(6) 2025, the patient came in presenting instability and the cause is unknown.The surgeon revised the insert with an insert of the same size (as 20 mm is the maximum available thickness).The soft tissue was sutured to restore stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 feb 2026.Lot 2237912: (b)(4) items manufactured and released on 10-oct-2022.Expiration date: 2027-sept-22.No anomalies found related to the problem.To date, one item of the same lot has been sold with no similar reported event during the period of review.Root cause: the surgeon revised the liner and sutured the soft tissue to restore joint stability.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 3R - 20MM
• 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: 24558219
• Report Number: 3005180920-2026-00174
• Device Sequence Number: 9331210
• Product Code: JWH
• UDI-Device Identifier: 07630971261723
• UDI-Public: 07630971261723
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/10/2026

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.E0320FR
• Device Lot Number: 2237912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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 Sex: Female
• Patient Race: American Indian Or Alaskan Native