MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 14 MM

Model Number	02.07.0314SCF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 feb 2026 gmk-revision 02.07.0314scf fixed tibial insert semiconstrained s.3 / 14 mm (k103170) lot 2213535: (b)(4) items manufactured and released on 21-sept-2022.Expiration date: 2027-aug-25.No anomalies found related to the problem.To date, 4 items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.2403r femur revision ps cemented s.3r (k102437) lot 2306564: (b)(4) items manufactured and released on 29-aug-2023.Expiration date: 2028-aug-29.No anomalies found related to the problem.To date, 9 items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.0683r revision tibial tray size 3 right - finishing (k123721) lot 2201248: (b)(4) items manufactured and released on 23-jun-2022.Expiration date: 2027-jun-10.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.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had revision right knee surgery of competitor implants to medacta implants on (b)(6) 2024.On (b)(6) 2025, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in to have antibiotic spacers that were put in on (b)(6) 2026 to treat infection with the pathogen unknown.The surgeon revised the tray and femoral component and upsized the liner from 14mm to 17mm to mitigate any bone loss from multiple surgeries that may have contributed to a leg length issue and resurfaced the natural patella bone.The surgery was completed successfully.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 14 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: 24518515
• Report Number: 3005180920-2026-00203
• Device Sequence Number: 9723197
• Product Code: JWH
• UDI-Device Identifier: 07630030817298
• UDI-Public: 07630030817298
• 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): 03/05/2026

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: 02.07.0314SCF
• Device Lot Number: 2213535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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