MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 12MM

Model Number	02.12.E0512FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 january 2026.Gmk-spherika 02.12.E0512fr gmk-sphere tibial insert e-cross - flex 5r - 12mm (k202022) lot 2345853: (b)(4) items manufactured and released on 21-dec-2023.Expiration date: 05-dec-2028.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.Gmk-spherika 02.12.Ka16r gmk spherika femoral component s6+r cemented (k211004) lot 2402435: (b)(4) items manufactured and released on 07-aug-2024.Expiration date: 24-jul-2029.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: the surgeon performed a tissue release, a common practice to restore joint mobility, and revised the liner using the standard procedure while maintaining the same thickness.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At about10 months from the primary, the patient came in presenting pain and limited range of extension and the cause is unknown.The surgeon revised the femoral component and insert from a 12mm to a 10mm.The surgery was completed successfully.
Additional Manufacturer Narrative
Root cause: the surgeon revised liner height, which is a common practice to restore the joint mobility.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 - 12MM
• 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: 24343895
• Report Number: 3005180920-2026-00101
• Device Sequence Number: 18619843
• Product Code: JWH
• UDI-Device Identifier: 07630971262089
• UDI-Public: 07630971262089
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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.E0512FR
• Device Lot Number: 2345853
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2023
• 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 Sex: Male