MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERE PATELLA RESURFACING SIZE 3

Model Number	02.07.0035RP
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 june 2025: (b)(4) items manufactured and released on 03 july 2020.Expiration date: 04 june 2025.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 there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2022, the patient came in reporting pain and the cause is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.Presently, on (b)(6) 2025 the patient came in reporting pain and a bone scan suggested a loose patella.The surgeon revised the patella and the surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE PATELLA RESURFACING SIZE 3
• 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: 22435818
• Report Number: 3005180920-2025-00637
• Device Sequence Number: 3153020
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Expiration Date: 06/04/2025
• Device Model Number: 02.07.0035RP
• Device Lot Number: 2003010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2020
• 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: 74 YR
• Patient Sex: Male
• Patient Race: White