MAUDE Adverse Event Report: Medacta International SA GMK Sphere Total Knee System; GMK-SPHERE tibial insert E-Cross - Flex 4L - 10mm

Model Number	02.12.E0410FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 4 months fro the primary, the patient came in reporting instability due to laxity and the cause of the laxity is unknown.The surgeon revised the gmk-sphere tibial insert from 10 mm to 13 mm to give the patient more stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 july 2026 gmk-spherika 02.12.E0410fl gmk-sphere tibial insert e-cross - flex 4l - 10mm (k202022) lot 2423955: (b)(4) items manufactured and released on 08-oct-2024.Expiration date: 23-sep-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Root cause:the surgeon revised liner height, which is a common practice to restore the 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 4L - 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: 50114136
• Report Number: 3005180920-2026-00814
• Device Sequence Number: 5305339
• Product Code: JWH
• UDI-Device Identifier: 07630971261754
• UDI-Public: 07630971261754
• 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
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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.E0410FL
• Device Lot Number: 2423955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2024
• 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: Unknown