MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 12MM

Model Number	02.12.E0412FL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 weeks from primary, the patient came in due to a dissociation of the insert from the tibial tray and the cause is unknown.The surgeon upsized the tray from a 12mm to a 13mm to prevent future dislocation.The surgery was completed successfully.The surgeon believed it wasn`t seated correctly during the initial surgery.
Additional Manufacturer Narrative
Batch review performed on 11 febr 2026.Gmk-spherika 02.12.E0412fl gmk-sphere tibial insert e-cross - flex 4l - 12mm (k202022) lot: 2433527: (b)(4) items manufactured and released on 27-jan-2025.Expiration date: 2030-jan-09.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.Gmk-spherika 02.07.1202r tibial tray fix cemented s.2r (k090988) lot: 2433855: (b)(4) items manufactured and released on 24-feb-2025.Expiration date: 2030-feb-06.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.Root cause: based on the information available no definitive root cause can be established.Considering previous similar events and the surgeon's comment, 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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 12MM
• 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: 24504539
• Report Number: 3005180920-2026-00168
• Device Sequence Number: 21299760
• Product Code: JWH
• UDI-Device Identifier: 07630971261839
• UDI-Public: 07630971261839
• 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): 03/04/2026

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.E0412FL
• Device Lot Number: 2433527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2025
• 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 Sex: Female