MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM

Model Number	02.12.E0511FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 november 2025.Lot 2409804: (b)(4) items manufactured and released on 23-may-2024.Expiration date: 2029-05-01.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 surgeon revised liner height, which is a common practice to restore joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At about 8 months after the primary, the patient came in reporting instability and the cause is unknown.The surgeon upsized the liner to give the patient more stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Correction: d9.Visual inspection performed by r&d department.Revision of a gmk sphere tibial insert due to instability after 8 months from the primary surgery.The 11 mm insert was replaced intraoperatively with a 14 mm insert to achieve the desired stability.The root cause of the initial instability remains unknown.Visual inspection of the returned 11 mm tibial insert revealed minor dents and scratches on the anterior 'snapping' fixation features, and a medium dent on the medial posterior surface of the insert, likely caused by insertion and removal during the procedure.No other anomalies or relevant findings were observed during the visual assessment.Based on the available evidence, there is no indication that the need to change the insert thickness due to instability was related to a defective device.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM
• 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: 23615346
• Report Number: 3005180920-2025-01154
• Device Sequence Number: 9051428
• Product Code: JWH
• UDI-Device Identifier: 07630971262041
• UDI-Public: 07630971262041
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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.E0511FR
• Device Lot Number: 2409804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White