MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6R - 13MM

Model Number	02.12.E0613FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Joint Laxity (4526)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 march 2026.Gmk-spherika 02.12.E0613fr gmk-sphere tibial insert e-cross - flex 6r - 13mm (k202022) lot: 2410737: (b)(4) items manufactured and released 13-jun-2024.Expiration date: 26-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: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had primary right knee surgery on (b)(6) 2025.On (b)(6) 2026, the patient came in due pain from patella arthritis and a torn arthrotomy as the result of a fall.The surgeon performed a washout and revised the patient`s natural patella and upsized the insert from 10mm to 13mm at his discretion.The surgery was completed successfully.On (b)(6) 2026, the patient came in due to torn arthrotomy and the cause is unknown.There was no communication that a fall or trauma caused the torn arthrotomy.The surgeon performed a washout and revised the 13mm insert to a same size insert.The surgery was completed successfully.Presently, the patient came in presenting pain due to a torn quad tendon that reportedly occurred when standing.The surgeon revised the insert from 13 mm to 14 mm at his discretion.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6R - 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: 24871723
• Report Number: 3005180920-2026-00285
• Device Sequence Number: 9878038
• Product Code: JWH
• UDI-Device Identifier: 07630971262362
• UDI-Public: 07630971262362
• 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): 04/14/2026

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.E0613FR
• Device Lot Number: 2410737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2024
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Race: White