MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 13MM

Model Number	02.12.E0313FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 november 2025: gmk-spherika 02.12.E0313fr gmk-sphere tibial insert e-cross - flex 3r - 13mm (k202022) lot 2319578: (b)(4) items manufactured and released on 14-aug-2023.Expiration date: 2028-jul-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.Gmk-spherika 02.15.E029 moto patella e-cross d 29 (k213071) lot 2418507: (b)(4) items manufactured and released on 14-aug-2024.Expiration date: 2029-jul-30.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 poly height and upsized the patella 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
The patient had primary knee surgery using a competitor product.On (b)(6) 2025, the patient was revised to medacta implants.On, (b)(6) 2025, the patient came in due to pain and feeling unstable and the cause is unknown.The surgeon upsized the poly and patella.The surgery was completed successfully.Upon removing the poly, the surgeon removed multiple bone spurs and cement chunks.
Event or Problem Description
The patient had primary knee surgery using a competitor product.On (b)(6) 2025, the patient was revised to medacta implants.On, (b)(6) 2025, the patient came in due to pain and feeling unstable and the cause is unknown.The surgeon upsized the poly and patella, implanting thicker implants.The surgery was completed successfully.Upon removing the poly, the surgeon removed multiple osteophytes due to patient pathology and cement chunks (competitor cement).
Additional Manufacturer Narrative
B5 updated.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 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: 23579961
• Report Number: 3005180920-2025-01135
• Device Sequence Number: 9398191
• Product Code: JWH
• UDI-Device Identifier: 07630971261648
• UDI-Public: 07630971261648
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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.E0313FR
• Device Lot Number: 2319578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Race: White