MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 14MM

Model Number	02.12.E0414FL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 july 2026 gmk-sphere 02.12.E0414fl gmk-sphere tibial insert e-cross - flex 4l - 14mm (k202022) lot.2525066: (b)(4) items manufactured and released on 16-oct-2025.Expiration date: 2030-10-02.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: based on the information available no definitive root cause can be established.It is likely that the insert was not correctly engaged with the tibial baseplate during the first revision, but this cannot be confirmed.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
Primary surgery performed on the (b)(6) 2024.First revision surgery performed on the (b)(6) 2026 due to knee laxity.Second revision surgery performed on the (b)(6) 2026 due to disengagement of the liner from the tibial tray.Explantation of the liner and implantation of a tibial insert fixed sphere flex using the dedicated torque limiter.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 14MM
• 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: 25854819
• Report Number: 3005180920-2026-00751
• Device Sequence Number: 14842421
• Product Code: JWH
• UDI-Device Identifier: 07630971261914
• UDI-Public: 07630971261914
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/17/2026

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: 02.12.E0414FL
• Device Lot Number: 2525066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White