MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S1

Model Number	02.12.E001RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Five months after the primary surgery, the patient presented with anterior knee pain of unknown origin.The surgeon reported that the patient had a low pain tolerance and questioned whether it was a true dislocation, suggesting that it might have been a patellar tilt, a more common postoperative occurrence in tka cases when the patella has been resurfaced.A lateral release of the patellar tendon was performed, followed by a washout and liner revision as per standard procedure.The surgery was successfully completed.
Additional Manufacturer Narrative
Batch review performed on 05 nov 2025 lot 2426003: (b)(4) items manufactured and released on 31 oct 2024.Expiration date: 13 oct 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.Root cause: based on the information available no definitive root cause can be established, while the device history record review does not indicate any potential manufacturing related issue.Although it cannot be confirmed, the issues reported may have resulted from application specific factors and/or damage of the particular components involved.No systemic issue can be identified at this time.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S1
• 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: 23583094
• Report Number: 3005180920-2025-01134
• Device Sequence Number: 9578415
• Product Code: JWH
• UDI-Device Identifier: 07630971260979
• UDI-Public: 07630971260979
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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.E001RP
• Device Lot Number: 2426003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2024
• 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 Sex: Female
• Patient Weight: 67 KG