MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE AND REVISION TINBN COATED; GMK-HINGE FEMORAL COMPONENT SIZE3 R - TINBN COATED

Model Number	02.09.2703R
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary right knee surgery using competitor implants.On (b)(6) 2023, the patient was revised from competitor products to medacta gmk-hinge.Presently, on (b)(6) 2026, the patient came presenting instability due to femoral and stem loosening and the cause is unknown.The surgeon revised the gmk-hinge femoral component to a same size femoral component, the gmk-hinge 14mm insert to a 17mm insert for stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 march 2026.Gmk-hinge 02.09.2703r gmk-hinge femoral component size3 r - tinbn coated (k210010) lot 2010969: (b)(4) items manufactured and released on 26-feb-2021.Expiration date: 07-feb-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.Gmk-hinge 02.07.Fcl16105 fluted extension stem d 16mm / l 105mm (k120790) lot 177672b: (b)(4) items manufactured and released on 27-apr-2023.Expiration date: 04-apr-2028.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 02.09.0414h gmk-hinge tibial insert - size4 - 14 mm (k130299) lot 2219279: (b)(4) items manufactured and released on 21-sep-2022.Expiration date: 31-aug-2027.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: the available x-ray image refers to the two-week postoperative period following the initial implantation of the hinged prosthesis.From this projection, the implant appears to be in a satisfactory position.No potential failure mechanism can be identified from this image, considering that the loosening was reported approximately three years later.In general, aseptic loosening is a well-described adverse event in the literature following tka, particularly in revision cases, and its causes are often multifactorial or unknown.In the present case, the available information is insufficient to determine the root cause.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 AND REVISION TINBN COATED
• Common Device Name: GMK-HINGE FEMORAL COMPONENT SIZE3 R - TINBN COATED
• 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: 24674593
• Report Number: 3005180920-2026-00237
• Device Sequence Number: 10204235
• Product Code: JWH
• UDI-Device Identifier: 07630040721844
• UDI-Public: 07630040721844
• Combination Product (Y/N): N
• PMA/510(K) Number: K210010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/24/2026

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 Expiration Date: 02/07/2026
• Device Model Number: 02.09.2703R
• Device Lot Number: 2010969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: White