MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 14MM

Model Number	02.12.E0314FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 april 2026: gmk-spherika 02.12.E0314fl gmk-sphere tibial insert e-cross - flex 3l - 14mm (k202022), lot: 2338079: (b)(4) items manufactured and released on 02-oct-2023.Expiration date: 2028-sep-18.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.Gmk-spherika 02.12.Ka13l gmk spherika femoral component s3+l cemented (k211004) lot: 2408287: (b)(4) items manufactured and released on 25-jun-2024.Expiration date: 2029-jun-11.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: the revision procedure, including increase of liner thickness, femoral component revision, and extension stem exchange to a longer fluted stem, was undertaken to address joint instability.Based on the available information, no device-related issues have been identified that could have caused or contributed to the event.
Event or Problem Description
The patient came in presenting instability, the reason is unknown.At about 1 year and 3 months post primary the surgeon performed a washout and revised the 14mm insert to a 17mm insert, revised the gmk-spherika s3 femoral component to a gmk-revision s4 femoral component, and revised the primay l30mm extension stem with a fluted l150mm extension stem.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 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: 25040713
• Report Number: 3005180920-2026-00367
• Device Sequence Number: 16044914
• Product Code: JWH
• UDI-Device Identifier: 07630971261679
• UDI-Public: 07630971261679
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• 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: 02.12.E0314FL
• Device Lot Number: 2338079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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