MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE 02.12.E0413FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 13MM

Model Number	02.12.E0413FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2025 lot 2110582: (b)(4) items manufactured and released on 04-oct-2021.Expiration date: 2026-09-20.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.Clinical evaluation performed by medacta medical director: about 2 years after primary tka, the patellofemoral articulation, untreated at index operation, becomes painful and needs surgery.The patella is resurfaced and in this occasion the insert is usually replaced, even if no working perfectly, to give the patient a new one.In this case, a thicker insert was chosen in order to restore stability, as some was lost due to secondary relaxation of ligaments.All devices were working properly and the surgery was due to disease progression.The surgeon revised 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
Secondary patella bone resurfacing due to persistent patellofemoral pain approximately 2 years and 3 months after initial surgery.Inlay replacement from 13mm to 17mm to further improve knee stability according to surgeons newer preferences.All other components remain in place.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE 02.12.E0413FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 13MM
• 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: 22479558
• Report Number: 3005180920-2025-00645
• Device Sequence Number: 8498415
• Product Code: JWH
• UDI-Device Identifier: 07630971261884
• UDI-Public: 07630971261884
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K202022
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: 09/20/2026
• Device Model Number: 02.12.E0413FR
• Device Lot Number: 2110582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female