MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; OFFSET CONNECTOR 5 MM

Model Number	02.07.0005
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Medical device site infection (4845)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 september 2025: gmk-revision 02.07.0510scf fixed tibial insert semiconstrained s.5 / 10 mm (k103170) lot 2116751: (b)(4) items manufactured and released on 20-jan-2022.Expiration date: 2027-01-06.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 02.07.0685l revision tibial tray size 5 left - finishing (k123721) lot 2341790: (b)(4) items manufactured and released on 09-feb-2024.Expiration date: 2029-01-23.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 02.07.2406l femur revision ps size 6 l (k102437) lot 2108722: (b)(4) items manufactured and released on 18-oct-2021.Expiration date: 2026-set-27.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.Fcl14065 fluted extension stem ø14mm / l 065mm (k120790) lot 2402453: (b)(4) items manufactured and released on 17-jun-2024.Expiration date: 2029-06-02.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.Fcl20065 fluted extension stem ø20mm / l 065mm (k120790) lot 189592a: (b)(4) items manufactured and released on 01-feb-2024.Expiration date: 2029-02-11.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold.Gmk-revision 02.07.0005 offset connector 5 mm (k102437) lot 2010868: (b)(4) items manufactured and released on 29-nov-2020.Expiration date: 2029-11-29.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Conclusions: 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 primary knee surgery (b)(6) 2025.The patient's first revision was on (b)(6) 2025 for an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.On (b)(6) 2025 the patient came in again due to infection with an unknown cause.The surgeon revised the gmk-revision system to a gmk-hinge system.The surgery was completed successfully.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: OFFSET CONNECTOR 5 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: 23291023
• Report Number: 3005180920-2025-00990
• Device Sequence Number: 4862403
• Product Code: JWH
• UDI-Device Identifier: 07630030815607
• UDI-Public: 07630030815607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 02.07.0005
• Device Lot Number: 2010868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2020
• 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 Sex: Male
• Patient Race: White