MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-REVISION TIBIAL TRAY FIX CEMENTED S.5

Model Number	02.07.1205R
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	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 october 2025: gmk-primary 02.07.1205r tibial tray fix cemented s.5r (k090988) lot 2207318: (b)(4) items manufactured and released on 05-aug-2022.Expiration date: 26-jul-2027.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-revision 02.07.2406r femur revision ps cemented s.6r (k102437) lot 180123: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 15-apr-2023.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-revision 02.07.0514scf fixed tibial insert semiconstrained s.5 / 14 mm (k103170) lot 1903726: (b)(4) items manufactured and released on 15-jul-2019.Expiration date: 02-jul-2024.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-revision 02.07.0514scf fixed tibial insert semiconstrained s.5 / 14 mm (k103170) lot 2200931: (b)(4) items manufactured and released on 28-mar-2022.Expiration date: 10-mar-2027.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient came in reporting instability for two times and the cause is unknown.The first episode occurred on (b)(6) 2024, at about 2 years after the primary surgery with medacta products.The surgeon revised only the liner (from 14 mm to 17 mm).The second episode occurred on (b)(6) 2025 the surgeon revised the insert, tray, and femur from gmk-revision to gmk-hinge.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-REVISION TIBIAL TRAY FIX CEMENTED S.5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 23423786
• Report Number: 3005180920-2025-01035
• Device Sequence Number: 15902366
• Product Code: JWH
• UDI-Device Identifier: 07630030819933
• UDI-Public: 07630030819933
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 02.07.1205R
• Device Lot Number: 2207318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2022
• 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 Sex: Unknown