MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE AND REVISION TINBN COATED; GMK-HINGE FEMORAL COMPONENT SIZE 2 L - TINBN COATED

Model Number	02.09.2702L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 4 months after primary, the patient came in reporting pain due to a loose femoral and tibial component and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02-may-2025: (b)(4) items manufactured and released on 17-feb-2021.Expiration date: 10-jan-2026.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: gmk-hinge 02.09.4801l gmk-hinge fixed tinbn coated tibial tray - 1l (k210010) lot.2011954 batch review performed on 02-may-2025: (b)(4) items manufactured and released on 09-feb-2021.Expiration date: 28-jan-2026.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: 2.5 years after constrained tka on a very heavy patient, hte components are found mobilized and revision is undertaken.Limited radiographical history is available, the only image supplied can probably be dated back at the pre-revision visit.The cement layer, particularly at tibial level, is fragmented and probably insufficient to hold firmly the implants, but having no history, we can't tell if this is an evolution or the situation after index surgery.The rather difficult condition of the patient bone and the extreme weight are certainly factors that contribute to make the treatment more challenging.We have no information as to previous surgeries or other reasons that led the surgeon to choose a constrained implant for the index surgery; it's possible that this was in turn a revision, or that insufficient soft tissue conditions demanded a mechanical constraint.There is no reason to suspect a defect in the implanted devices, but a complete analysis cannot be performed with the information at hand.Root cause: the rather difficult condition of the patient bone and the extreme weight are certainly factors that contribute to make the treatment more challenging.We have no information as to previous surgeries or other reasons that led the surgeon to choose a constrained implant for the index surgery; it's possible that this was in turn a revision, or that insufficient soft tissue conditions demanded a mechanical constraint.There is no reason to suspect a defect in the implanted devices, but a complete analysis cannot be performed with the information at hand.

• Brand Name: GMK HINGE AND REVISION TINBN COATED
• Common Device Name: GMK-HINGE FEMORAL COMPONENT SIZE 2 L - TINBN COATED
• 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: 22087023
• Report Number: 3005180920-2025-00446
• Device Sequence Number: 17869104
• Product Code: JWH
• UDI-Device Identifier: 07630040721813
• UDI-Public: 07630040721813
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K210010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/27/2025

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: 01/10/2026
• Device Model Number: 02.09.2702L
• Device Lot Number: 2010966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2021
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 215 KG
• Patient Race: White