MAUDE Adverse Event Report: Medacta International SA GMK Revision Total Knee System; Fixed Tibial insert Semiconstrained S.5 / 17 mm

Model Number	02.07.0517SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to knee instability after about 3 years and 7 months from primary.The surgeon revised the femur with a femur of the same size with distal and posterior augments and upsized the poly for more stability.
Additional Manufacturer Narrative
Batch review performed on 29 july 2026 gmk-revision 02.07.0517scf fixed tibial insert semiconstrained s.5 / 17 mm (k103170) lot.2200931: (b)(6) items manufactured and released on 28-mar-2022.Expiration date: 2027-march-10.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with one similar reported events during the period of review.Gmk-revision 02.07.2406r femur revision ps cemented s.6r (k102437) lot.2102200: (b)(6) items manufactured and released on 04-may-2021.Expiration date: 2026-apr-22.No anomalies found related to the problem.To date, (b)(6) 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.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: GMK Revision Total Knee System
• Common Device Name: Fixed Tibial insert Semiconstrained S.5 / 17 mm
• 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: 50114122
• Report Number: 3005180920-2026-00821
• Device Sequence Number: 5468341
• Product Code: JWH
• UDI-Device Identifier: 07630030818578
• UDI-Public: 07630030818578
• Combination Product (Y/N): N
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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: 02.07.0517SCF
• Device Lot Number: 2200931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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 Age: 39 YR
• Patient Sex: Female