MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE AND REVISION TINBN COATED; TINBN COATED FEMUR REVISION PS SIZE 5 L

Model Number	02.07.4405L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to loose tibial and femoral components about 1 year and 3 months after the first revision surgery.The patient had primary left knee surgery using competitor products and was revised to medacta gmk-revision implants.The surgeon revised the femur, revised tibial tray, and revised the size 4 14mm semiconstrained liner to a 20mm gmk-hinge insert to address the instability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01 april 2026.Gmk-revision 02.07.4405l tinbn coated femur revision ps size 5 l lot 2303982 (k210010): (b)(4) items manufactured and released on 02-nov-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 without any similar reported event during the period of review.Gmk-revision 02.07.0414scf fixed tibial insert semiconstrained s.4 / 14 mm lot 2308262 (k103170): (b)(4) items manufactured and released on 22-dec-2023.Expiration date: 2028-dec-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK HINGE AND REVISION TINBN COATED
• Common Device Name: TINBN COATED FEMUR REVISION PS SIZE 5 L
• 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: 24826103
• Report Number: 3005180920-2026-00310
• Device Sequence Number: 21121791
• Product Code: JWH
• UDI-Device Identifier: 07630971258013
• UDI-Public: 07630971258013
• Combination Product (Y/N): N
• PMA/510(K) Number: K210010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/09/2026

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: 02.07.4405L
• Device Lot Number: 2303982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White