MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM

Model Number	02.12.E0210FR
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	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 august 2025: gmk-sphere 02.12.E0210fr gmk-sphere tibial insert e-cross - flex 2r - 10mm (k202022) lot 2405540: (b)(4) items manufactured and released on 13-mar-2024.Expiration date: 25-feb-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.Moto partial knee 02.15.E029 moto patella e-cross ø29 (k213071) lot 2344514: (b)(4) items manufactured and released on 05-feb-2024.Expiration date: 16-jan-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.The surgeon revised liner height, which is a common practice to restore the joint stability.Patellar implant was also revised due to generic pain and instability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in reporting pain due to a patella tendon rupture and the cause is unknown.The surgeon preformed a poly tendon repair and revised the poly.The surgery was completed successfully.On (b)(6) 2025, the patient came in reporting patella pain and instability, and the cause is unknown.The surgeon revised the medacta patella with a competitor patella and upsized the poly (from 10 to 12 mm) to address the instability.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM
• 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: 22902792
• Report Number: 3005180920-2025-00818
• Device Sequence Number: 20837610
• Product Code: JWH
• UDI-Device Identifier: 07630971261280
• UDI-Public: 07630971261280
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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.E0210FR
• Device Lot Number: 2405540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White