MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SINCE 4/14MM

Model Number	02.09.0414H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 july 2025: lot: 2308706: (b)(4) items manufactured and released on 31-july-2023.Expiration date: 2028-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional device involved, batch review performed on 28 july 2025: gmk-hinge 02.09.He14 gmk-hinge post extension 14 mm -tinbn coated (02.09.He14) lot: 2406098: (b)(4) items manufactured and released on 27-may-2024.Expiration date: 2029-05-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events 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 a primary knee surgery on (b)(6) 2024.On (b)(6) 2025, the patient came in reporting pain after falling and dislocating the femoral tibial joint.The surgeon revised the femoral component, tibial component and insert.The surgery was completed successfully.Presently on (b)(6) 2025, the patient came due to signs of infection with the cause unknown.The surgeon revised the liner and post and the surgery was completed successfully.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL INSERT SINCE 4/14MM
• 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: 22769927
• Report Number: 3005180920-2025-00747
• Device Sequence Number: 9342353
• Product Code: KRO
• UDI-Device Identifier: 07630030825200
• UDI-Public: 07630030825200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• 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
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 02.09.0414H
• Device Lot Number: 2308706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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