MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING

Model Number	02.07.2802L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 10 months after the primary, the patient underwent revision surgery due to tibial tray loosening.X-rays showed the prosthesis to be correctly positioned, although the patient reported pain and the bone scan showed increased uptake.During revision, no cement traces were observed on the tibial side, and only a small residue was found on the femoral side.
Additional Manufacturer Narrative
Batch review performed on 4 december 2025.Gmk-sphere 02.07.2802l fixed tibial tray size 2 l - tinbn coating (k202684) lot: 2219071: (b)(4) items manufactured and released on 25-jan-2023.Expiration date: 09-jan-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.Clinical and r& d analysis.A total knee revision surgery was performed approximately one year after the primary cemented total knee arthroplasty due to mobilization of the tibial component.Photographic documentation of the explanted components shows no cement remaining on the tibial baseplate, while residual cement was observed on portions of the femoral component.This differential finding may indicate a localized issue at the tibial cement-implant interface, potentially originating during the cementation phase and resulting in inadequate adhesion.The cementation process can be influenced by multiple factors, including implant and operating room temperature, timing of cement application and component insertion, presence of fluids or contaminants at the bone-cement or implant-cement interface, and potential deviations in cement handling, transportation, or storage (e.G., transient exposure to elevated temperatures), as well as procedural or environmental factors unrelated to the implant design or manufacture.Based on the information currently available, there is insufficient evidence to establish a definitive root cause or to attribute the event to a faulty device.Root cause:based on the information available, no definitive root cause can be established.Photographic review of the explanted components showed no cement on the tibial baseplate, suggesting a potential localized issue during the cementation phase, likely influenced by surgical or environmental factors rather than the implant itself.There is no indication that the device contributed to the event or that any manufacturing-related issue occurred.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING
• 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: 23854083
• Report Number: 3005180920-2025-01265
• Device Sequence Number: 10374418
• Product Code: JWH
• UDI-Device Identifier: 07630030821783
• UDI-Public: 07630030821783
• Combination Product (Y/N): N
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 12/19/2025

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 Model Number: 02.07.2802L
• Device Lot Number: 2219071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White