MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 12 MM

Model Number	02.07.0512SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At 10 months from medacta primary surgery, the patient came in presenting pain and severe flexion contracture and the cause is unknown.There were no reports of trauma.The surgeon revised the semiconstrained 12mm s5 insert to a semiconstrained 10mm s5 insert, performedadditional distal resection to gain full extensionand revised the ps size 5 r femur with the same size femur along with augments.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 may 2026 gmk-revision 02.07.0512scf fixed tibial insert semiconstrained s.5 / 12 mm (k103170) lot 2210522: (b)(4) items manufactured and released on 07-jun-2022.Expiration date: 2027-may-19.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 02.07.4405r tinbn coated femur revision ps size 5 r (k210010) lot 2303983: (b)(4) items manufactured and released on 25-oct-2023.Expiration date: 2028-oct-10.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.Root cause: the surgeon revised the devices to restore joint mobility.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: FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 12 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: 25185346
• Report Number: 3005180920-2026-00453
• Device Sequence Number: 10653240
• Product Code: JWH
• UDI-Device Identifier: 07630030818332
• UDI-Public: 07630030818332
• Combination Product (Y/N): N
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/15/2026

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: 02.07.0512SCF
• Device Lot Number: 2210522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: Male