MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT - FLEX S5L - 14 MM

Model Number	02.12.0514FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 november 2025.Lot 2005775: (b)(4) items manufactured and released on 03-sep-2020.Expiration date: 23-aug-2025.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 revised liner height, which is a common practice to restore the joint stability.Patella bone was also resurfaced as it was not resurfaced at the primary surgery.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 came in due to knee pain.The surgeon observed patella maltracking issues and laxity.About 2 years and 4 months after the primary surgery, the surgeon upsized the insert (from 14mm to 17mm) and resurfaced the patient & size 39s natural patella.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT - FLEX S5L - 14 MM
• 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: 23615705
• Report Number: 3005180920-2025-01166
• Device Sequence Number: 10045261
• Product Code: JWH
• UDI-Device Identifier: 07630030826818
• UDI-Public: 07630030826818
• Combination Product (Y/N): N
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 11/21/2025

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 Expiration Date: 08/23/2025
• Device Model Number: 02.12.0514FL
• Device Lot Number: 2005775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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: Male