MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT - FLEX S4R - 13 MM

Model Number	02.12.0413FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 november 2025: lot 2112464: (b)(4) items manufactured and released on 10-nov-2021.Expiration date: 2026-oct-25.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: the surgeon will revise the liner height, which is a common practice to restore the 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 3 years and 1 month post primary, the patient reports knee pain, swelling under the patella, and stiffness after sitting or in the morning, but no night pain.Patient exam ((b)(6) 2025): mild medial-lateral laxity (more in flexion), no anterior laxity, implant stable, patella tracking centrally.On (b)(6) 2025, the complaint notifier reported: no infection or implant loosening; laxity likely due to intense activity stretching ligaments.
Additional Manufacturer Narrative
Fu1: revision surgery performed on (b)(6) 2026.Event description updated.
Event or Problem Description
At about 3 years and 1 month post primary, the patient reports knee pain, swelling under the patella, and stiffness after sitting or in the morning, but no night pain.Patient exam ((b)(6) 2025): mild medial-lateral laxity (more in flexion), no anterior laxity, implant stable, patella tracking centrally.On (b)(6) 2025 the complaint notifier reported: no infection or implant loosening; laxity likely due to intense activity stretching ligaments.Revision surgery performed on (b)(6) 2026, size 16 custom liner implanted successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT - FLEX S4R - 13 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 23615352
• Report Number: 3005180920-2025-01150
• Device Sequence Number: 9051431
• Product Code: JWH
• UDI-Device Identifier: 07630030862632
• UDI-Public: 07630030862632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 02.12.0413FR
• Device Lot Number: 2112464
• Was Device Available for Evaluation?: 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: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Unknown