MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; GMK-REVISION EXTENSION STEM - FLUTED Ø 16 L 65

Model Number	02.07.FCL16065
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-04-2025: lot 2318113: (b)(4) items manufactured and released on 08-11-2023.Expiration date: 2028-10-18.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Additional devices involved batch reviews performed on 16-04-2025: gmk-revision 02.07.0683r revision fixed tibial tray cemented size 3 r (k123721) lot 2336251: 23 items manufactured and released on 29-01-2024.Expiration date: 2029-01-13.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Gmk-revision 02.07.0312scf fixed tibial insert sc size 3/12mm (k103170) lot 2342620: (b)(4) items manufactured and released on 29-02-2024.Expiration date: 2029-01-14.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Gmk-revision 02.07.Fcl18065 extension stem - fluted ø 18 l 65 (k120790) lot 2335705: (b)(4) items manufactured and released on 28-11-2023.Expiration date: 2028-11-12.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Gmk-revision 02.07.2403r femur revision ps size 3 r (k102437) lot 2342499: (b)(4) items manufactured and released on 04-03-2024.Expiration date: 2029-02-14.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Gmk-revision 02.07.0003 offset connector 3 mm (k102437) lot 2347061: (b)(4) items manufactured and released on 01-03-2024.Expiration date: 2029-02-18.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Clinical evaluation performed clinical affairs department: 1 year after a difficult tka revision, the knee gets infected and the components need revision.Secondary postoperative infections are a known possible adverse event after tka, and in revision cases the occurrence is higher.No reason to suspect a malfunctioning device at the origin of this adverse event.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
At about 11 months from primary the patient was revised due to infection.All devices explanted and surgery completed successfully.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: GMK-REVISION EXTENSION STEM - FLUTED Ø 16 L 65
• 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: 22016286
• Report Number: 3005180920-2025-00380
• Device Sequence Number: 12922021
• Product Code: JWH
• UDI-Device Identifier: 07630030823022
• UDI-Public: 07630030823022
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120790
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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.FCL16065
• Device Lot Number: 2318113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White