MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; PATELLA RESURFACING S.1 (NEW GENERATION)

Model Number	02.07.0033RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 june 2026: lot 2102134: (b)(4) items manufactured and released on 07-apr-2021.Expiration date: 24-mar-2026.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 for the reported patellar tracking issue and related pain.The device history record review does not indicate any potentially related manufacturing issue.In addition, there is no indication of trauma or of any device-related issue that may have caused or contributed to the event.
Event or Problem Description
The patient had pain due to the patella not tracking properly and the cause is unknown.There was no indication of trauma.At about 4 years and 10 months post primary the surgeon revised the medacta patella to a competitor patella.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: PATELLA RESURFACING S.1 (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: 25763502
• Report Number: 3005180920-2026-00675
• Device Sequence Number: 9787528
• Product Code: JWH
• UDI-Device Identifier: 07630030815737
• UDI-Public: 07630030815737
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 07/09/2026

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 Expiration Date: 03/24/2026
• Device Model Number: 02.07.0033RP
• Device Lot Number: 2102134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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 Sex: Female