MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 12MM

Model Number	02.12.E0212FR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 months from the primary, the patient presented with pain due to a dislocation between the cemented femoral component and tibial insert and the cause is unknown.The surgeon revised the femur from gmk-spherika to a gmk-revision and the insert (from 12mm to 17mm).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 january 2026.Gmk-spherika 02.12.E0212fr gmk-sphere tibial insert e-cross - flex 2r - 12mm (k202022) lot: 2427169: (b)(4) items manufactured and released on 24-oct-2024.Expiration date: 09-oct-2029.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 02.12.Ka12r gmk spherika femoral component s2+r cemented (k211004) lot: 2400546: (b)(4) items manufactured and released on 27-may-2024.Expiration date: 12-may-2029.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: implant dislocation is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 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: 24429833
• Report Number: 3005180920-2026-00114
• Device Sequence Number: 10304348
• Product Code: JWH
• UDI-Device Identifier: 07630971261365
• UDI-Public: 07630971261365
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/24/2026

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.E0212FR
• Device Lot Number: 2427169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2024
• 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: Unknown