MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK IMPLANTS; TIBIAL TRAY FIX CEMENTED S.2L

Model Number	02.07.1202L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 2 years and 6 months from the primary surgery, the patient presented with loosening of the tibial tray.There was no loosening of the femoral component.The surgeon revised the tibial tray and insert with a gmk-revision tibial tray with wedges, offset, and extension stem.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25-september-2025.Gmk-sphere 02.07.1202l tibial tray fix cemented s.2l lot.2241999: (b)(4) items manufactured and released on 02-february-2023.Expiration date: 18-january-2028.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.Conclusions: aseptic loosening is a possible literature-described adverse event after primary knee arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: GMK IMPLANTS
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.2L
• 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: 23299144
• Report Number: 3005180920-2025-00988
• Device Sequence Number: 10027668
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/14/2025

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: 01/18/2025
• Device Model Number: 02.07.1202L
• Device Lot Number: 2241999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 79 KG