MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FEMORAL COMPONENT R - SIZE2

Model Number	02.09.2602R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 aug 2025.Gmk-hinge 02.09.2602r gmk-hinge femoral component r - size2 (k130299) lot 2100750: (b)(4) items manufactured and released on 17-may-2021.Expiration date: 2026-apr-29.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.Additional devices involved: gmk-hinge 02.09.4002r gmk-hinge tibial tray - 2r (k130299) lot 2013006: (b)(4) items manufactured and released on 28-apr-2021.Expiration date: 2026-apr-13.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.Gmk-hinge 02.07.Fcl15065 fluted extension stem ø15mm / l 065mm (k120790) lot.2100203: (b)(4) items manufactured and released on 28-jun-2021.Expiration date: 2026-jun-14.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.Clinical evaluation performed by clinical affair department: a revision surgery was performed approximately four years after the implantation of a hinged knee prosthesis, due to aseptic loosening.The available radiographic images clearly demonstrate signs of implant mobilization, particularly evident as radiolucent lines around the femoral stem of the prosthesis.Aseptic loosening is a well-documented complication in the literature, often associated with multifactorial or unclear etiology.In this case as well, the exact cause of failure is difficult to determine based on the available information.However, there are no elements to suggest a defective or malfunctioning device.
Event or Problem Description
Revision surgery due to aseptic loosening of primary hinge prothesis with uncemented stems at 3 years 10 months from primary.No recutting of the tibia and femur.Reimplantation of the hinge system with cemented components and sensitin implants.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE FEMORAL COMPONENT R - SIZE2
• 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: 22961215
• Report Number: 3005180920-2025-00839
• Device Sequence Number: 8259811
• Product Code: KRO
• UDI-Device Identifier: 07630030825422
• UDI-Public: 07630030825422
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/04/2025

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 Expiration Date: 04/29/2026
• Device Model Number: 02.09.2602R
• Device Lot Number: 2100750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2021
• 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: 61 YR
• Patient Sex: Female