MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.3R

Model Number	02.07.1203R
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 july 2026 lot 2004701: (b)(4) items manufactured and released on 05-oct-2020.Expiration date: 23-sep-2015.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.
Event or Problem Description
Revision surgery due to tibial subsidence after about 5 years and 4 months from primary.The surgeon revised tibial tray and insert.The patient had a first revision surgery on (b)(6) 2023 where the surgeon revised the femoral component and tibial insert (mdr 3005180920-2023-00515)-.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.3R
• 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: 25838727
• Report Number: 3005180920-2026-00747
• Device Sequence Number: 5737765
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/16/2026

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 Expiration Date: 09/23/2025
• Device Model Number: 02.07.1203R
• Device Lot Number: 2004701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White