MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FEMORAL COMPONENT L - SIZE3

Model Number	02.09.2603L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 months from the primary, the patient came reporting knee pain and instability.A bone scan revealed that, in the gmk hinge system, both the tibial and femoral components were loose, while the stems appeared well fixed.The surgeon disassociated the stems from the femoral and tibial components in situ and revised both the femur and tibia.To recouple the newly revised femur, the surgeon added an offset to the stem left in the body.The tibia was recoupled to the original stem without the use of an offset.The procedure was completed successfully.The surgeon did not follow the correct procedure for the gmk hinge system.The surgeon was reminded of the proper indications for use and the correct surgical technique for the gmk hinge system and provided them with the ifu and surgical technique documentation.
Additional Manufacturer Narrative
Batch review performed on 09 february 2026.Gmk-hinge 02.09.2603l gmk-hinge femoral component l - size3 (k130299) lot 2411953a: (b)(4) items manufactured and released on 24-jun-2024.Expiration date: 07-jun-2029.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-hinge 02.09.4002l gmk-hinge tibial tray - 2l (k130299) lot 2110163: (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 07-oct-2026.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 this is a case of revision surgery performed approximately 7 months after the implantation of a hinged knee prosthesis, due to reported loosening of both the tibial and femoral components.The radiographic images provided refer exclusively to the postoperative condition following the revision procedure.Therefore, no direct radiological assessment of the pre-revision status or of the mechanisms leading to loosening can be performed.However, aseptic loosening is a well-recognized complication described in the literature, particularly in complex revision knee arthroplasty procedures.Its etiology is often multifactorial and, in many cases, the precise underlying cause cannot be definitively identified.Based on the available postoperative images, no evident abnormalities in component positioning, fixation, or alignment are observed.However, according to the report, the previously implanted femoral and tibial stems were left in situ and the new components were assembled outside the recommended surgical technique.In light of this deviation, the mechanical performance of the construct cannot be assessed or guaranteed based on the information available.R&d analysis and additional information.R&d analysis confirmed that the surgeon did not follow the correct procedure for the gmk hinge system.The stems were disassociated in situ from the femoral and tibial components, which were revised, instead of revising the stems as well, as required by the surgical technique.On (b)(6) 2026, the branch informed us that the surgeon was reminded of the proper indications for use of the gmk hinge system.Root cause: aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE FEMORAL COMPONENT L - SIZE3
• 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: 24481879
• Report Number: 3005180920-2026-00165
• Device Sequence Number: 9306077
• Product Code: KRO
• UDI-Device Identifier: 07630030825439
• UDI-Public: 07630030825439
• Combination Product (Y/N): N
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/02/2026

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: 02.09.2603L
• Device Lot Number: 2411953A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2024
• 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: Female
• Patient Race: White