MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; GMK-REVISION FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 14 MM

Model Number	02.07.0214SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year and 1 month after the primary surgery, the patient presented with instability of unknown cause.The surgeon upsized both the insert and the peg from 14 mm to 17 mm to improve stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 october 2025: gmk-revision 02.07.0214scf fixed tibial insert semiconstrained s.2 / 14 mm ( k103170) lot.2008655: (b)(4) items manufactured and released on 28 sept 2020.Expiration date: 07 sept 2025.No anomalies found related to the problem.To date, 26 items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.Scp14 tinbn coated sc peg - 14mm (k210010) lot.2341851: (b)(4) items manufactured and released on 29 jan 2024.Expiration date: 08 jan 2029.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.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 REVISION TOTAL KNEE SYSTEM
• Common Device Name: GMK-REVISION FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 14 MM
• 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: 23437043
• Report Number: 3005180920-2025-01064
• Device Sequence Number: 20007383
• Product Code: JWH
• UDI-Device Identifier: 07630030816710
• UDI-Public: 07630030816710
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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 Expiration Date: 09/07/2025
• Device Model Number: 02.07.0214SCF
• Device Lot Number: 2008655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2020
• 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: 71 YR
• Patient Sex: Female