MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; GMK-REVISION REVISION TIBIAL TRAY SIZE 2 LEFT

Model Number	02.07.0682L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 october 2025: gmk-revision 02.07.0682l revision tibial tray size 2 left (k123721) lot 2009564: (b)(4) items manufactured and released on 11-jan-2021.Expiration date: 20-dec-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.Gmk-revision 02.07.2403l femur revision ps cemented s.3l (k102437) lot 2008812: (b)(4) items manufactured and released on 28-oct-2020.Expiration date: 11-oct-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.Conclusion: 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
On (b)(6) 2022, the patient had primary left knee surgery.On (b)(6) 2022, the patient had knee pain.The surgeon decided to revise the patient and discovered that tibia, femur, and patella were loose and did not bond with the cement.The cause of this is unknown.The surgeon revised all implants.Mdr 3005180920-2022-00412.On (b)(6) 2025, the patient had knee pain due to loosening of the cemented femoral and tibial components.The surgeon revised all components to gmk-revision and added cones from a competitor.The resurfaced patella from the first revision was retained.The surgery was completed successfully.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: GMK-REVISION REVISION TIBIAL TRAY SIZE 2 LEFT
• 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: 23532098
• Report Number: 3005180920-2025-01098
• Device Sequence Number: 18427100
• Product Code: JWH
• UDI-Device Identifier: 07630030819346
• UDI-Public: 07630030819346
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 11/12/2025

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: 12/20/2025
• Device Model Number: 02.07.0682L
• Device Lot Number: 2009564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2021
• 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