MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.4R

Model Number	02.07.1204R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 june 2025.(b)(4) items manufactured and released on 12-apr-2022.Expiration date: 2027-03-24.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.Additional devices revised: gmk-sphere 02.12.0005r sphere femur cemented right s5 (k121416) lot.2217020 batch review performed on 30 june 2025.(b)(4) items manufactured and released on 28-sep-2022.Expiration date: 2027-09-16.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-sphere 02.12.0411fr sphere insert flex right 11mm s4 (k140826) lot.2201062 batch review performed on 30 june 2025.(b)(4) items manufactured and released on 05-apr-2022.Expiration date: 2027-03-17.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.
Event or Problem Description
The patient had instability.The cause of the instability is unknown.At about 2 years and 2 months post primary the surgeon revised the patient to a hinge knee.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.4R
• 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: 22477786
• Report Number: 3005180920-2025-00665
• Device Sequence Number: 18152843
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/24/2025

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: 02.07.1204R
• Device Lot Number: 2118043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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: Female