MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.5L

Model Number	02.07.1205L
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation a revision surgery was performed approximately 2 years after primary gmk sphere total knee arthroplasty due to pain and instability, with tibial tray subsidence into the proximal tibia, as visible in the radiographic images provided.No traumatic event or pre-existing bone quality issues were reported.The revision was completed successfully with a revision tibial tray with augments, stem and offset connector, and a thinner insert.Tibial subsidence in the absence of trauma is a multifactorial event, potentially related to insufficiency fracture of the proximal tibia, early aseptic loosening, fixation-related factors, or subclinical bone quality issues, all of which are described in the literature as possible adverse events after primary tka.Based on the available information, the exact root cause cannot be determined, and no evidence of device malfunction or manufacturing defect has been identified.Batch review performed on 08 april 2026 gmk-sphere 02.07.1205l tibial tray fix cemented s.5l (k090988) lot.2345309: (b)(4) items manufactured and released on 04-mar-2024.Expiration date: 2029-feb-18.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.12.E0512fl gmk-sphere tibial insert e-cross - flex 5l - 12mm (k202022) lot.2249840: (b)(4) items manufactured and released on 26-apr-2023.Expiration date: 2028-apr-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: tibial subsidence in the absence of trauma is a multifactorial event, potentially related to insufficiency fracture of the proximal tibia, early aseptic loosening, fixation-related factors, or subclinical bone quality issues, all of which are described in the literature as possible adverse events after primary tka.Based on the available information, the exact root cause cannot be determined, and no evidence of device malfunction or manufacturing defect has been identified.
Event or Problem Description
Revision surgery due to instability after about 1 year and 10 months from primary surgery.The surgeon observed that the tibial tray subsided into the tibia.The surgeon revised the tibial tray to a revision tibial tray with augments and stem and offset connector.The surgeon also revised the 12mm 5l insert to an 11mm 4l insert.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.5L
• 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: 25039772
• Report Number: 3005180920-2026-00348
• Device Sequence Number: 13364827
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/30/2026

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: 02.07.1205L
• Device Lot Number: 2345309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2024
• 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: Male
• Patient Race: White