MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM

Model Number	02.12.E0410FR
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	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years 5 months after the primary, the patient came in presenting instability in the right knee and the cause is unknown.The surgeon revised the gmk-sphere to a gmk-hinge system.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 february 2026.Gmk-sphere 02.12.E0410fr gmk-sphere tibial insert e-cross - flex 4r - 10mm (k202022) lot 2307913: (b)(4) items manufactured and released on 11-may-2023.Expiration date: 2028-04-26.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.12.T3i4r gmk-sphere tibial component cemented t3i4r (k121416) lot 2006484: (b)(4) items manufactured and released on 19-oct-2020.Expiration date: 2025-10-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.12.0004r gmk-sphere femoral component cemented - 4r (k121416) lot 1902416: (b)(4) items manufactured and released on 25-june-2019.Expiration date: 2024-06-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause:developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM
• 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: 24558211
• Report Number: 3005180920-2026-00212
• Device Sequence Number: 21164989
• Product Code: JWH
• UDI-Device Identifier: 07630971261761
• UDI-Public: 07630971261761
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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.E0410FR
• Device Lot Number: 2307913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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: 64 YR
• Patient Sex: Female
• Patient Race: White