MAUDE Adverse Event Report: Medacta International SA GMK Primary Total Knee System; Patella resurfacing S.2 (New generation)

Model Number	02.07.0034RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to patella maltracking and dislocation after about 1 year and 4 months from primary.All knee implants were revised using competitors implants.The primary was performed using myknee patient match cutting block.
Additional Manufacturer Narrative
Patient match planning review knee the analysis of the process found out no errors: each step of the mysolutions process has been performed accordingly with the working instructions batch review performed on 27 july 2026 lot 2425998: (b)(6) items manufactured and released on 31-oct-2024.Expiration date: 2029-oct-15.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: no definitive root cause could be established.The myknee planning review identified no errors or potentially related manufacturing issues; however, the absence of post-operative imaging prevented assessment of the actual implant positioning and other clinical or surgical factors.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK Primary Total Knee System
• Common Device Name: Patella resurfacing S.2 (New generation)
• 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: 50114124
• Report Number: 3005180920-2026-00806
• Device Sequence Number: 5468342
• Product Code: JWH
• UDI-Device Identifier: 07630030815751
• UDI-Public: 07630030815751
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 02.07.0034RP
• Device Lot Number: 2425998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/03/2026
• 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 Age: 68 YR
• Patient Sex: Male