MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 13MM

Model Number	02.12.E0413FL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 apr 2026 gmk-sphere 02.12.E0413fl gmk-sphere tibial insert e-cross - flex 4l - 13mm (k202022) lot 2002483: (b)(4) items manufactured and released on 16-jul-2020.Expiration date: 2025-jul-02.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.1204l tibial tray fix cemented s.4l (k090988) lot.2236487: (b)(4) items manufactured and released on 09-dec-2022.Expiration date: 2027-nov-24.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 performed by r&d project manager approximately three years after primary gmk-sphere tka, the patient underwent revision surgery due to disengagement of the polyethylene tibial insert from the tibial tray.No traumatic event was reported.According to the available radiographic description, there are no evident signs of component loosening.Although the polyethylene insert is difficult to visualize due to its radiolucent nature, the lateral projection appears to suggest posterior lifting / displacement of the insert, compatible with loss of its intended seating within the tibial tray.In the absence of trauma, the mechanism of insert disengagement cannot be determined with certainty.Plausible contributing factors may include patient-related or biomechanical factors, or suboptimal seating of the insert at the index procedure.However, these remain hypotheses, as no detailed intraoperative findings or assessment of the locking interface are currently available.Based on the available information, there is no confirmed evidence of a manufacturing defect or device malfunction.Root cause: based on the information available no definitive root cause can be established.Based on previous similar events, it is likely that the insert was not correctly inserted in the tibial baseplate during the primary surgery, but this cannot be confirmed.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
At 3 years 1 month from primary, the patient came in presenting pain due to a disengagement of the liner from the tibial tray.There was no trauma indicated and the surgeon did not have any issues snapping the poly in during the primary surgery.The surgeon performed a washout and revised the insert with one of the same size.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 13MM
• 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: 25148977
• Report Number: 3005180920-2026-00423
• Device Sequence Number: 16138564
• Product Code: JWH
• UDI-Device Identifier: 07630971261877
• UDI-Public: 07630971261877
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• 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): 05/12/2026

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: 07/02/2025
• Device Model Number: 02.12.E0413FL
• Device Lot Number: 2002483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White