MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 13MM

Model Number	02.12.E0413FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to knee stiffness patient came in presenting stiffness about 1 year and 4 months after primary surgery.The surgeon revised 13mm insert to a 20mm insert, revised the femoral component to a tinbn coated femoral component, and revised the tibial tray to a tinbn coated tibial tray.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 march 2026.Gmk-spherika 02.12.E0413fl gmk-sphere tibial insert e-cross - flex 4l - 13mm lot 2335816 (k202022): (b)(4) items manufactured and released on 22-sep-2023.Expiration date: 2028-sep-04.No anomalies found related to the problem.To date, 28 items of the same lot have been sold with no similar reported event during the period of review.Gmk-spherika 02.12.Ka04l gmk spherika femoral component s4l cemented lot 2411255 (k211004): (b)(4) items manufactured and released on 02-sep-2024.Expiration date: 2029-jul-26.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-spherika 02.07.1204l gmk tibial tray cemented left s4 lot 2411902 (k090988): (b)(4) items manufactured and released on 22-jul-2024.Expiration date: 2029-jul-05.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.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 4L - 13MM
• 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: 24871666
• Report Number: 3005180920-2026-00335
• Device Sequence Number: 10020100
• Product Code: JWH
• UDI-Device Identifier: 07630971261877
• UDI-Public: 07630971261877
• 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: 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): 04/14/2026

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.E0413FL
• Device Lot Number: 2335816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: White