MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.3L

Model Number	02.07.1203L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 oct 2025.Gmk-sphere 02.07.1203l tibial tray fix cemented s.3l (k090988) lot 2236484: (b)(4) items manufactured and released on 13-dec-2022.Expiration date: 2027-nov-27.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.Gmk-sphere 02.12.0023l gmk-sphere femoral component cemented - 3+l (k140826) lot.2217027: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-sept-29.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.Gmk-sphere 02.12.0310crl gmk sphere cr tibial insert s3l 10mm (k181635) lot.185581: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-sept-19.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
At2 years 7 months from primary, the patient came in reporting instability and the cause is unknown.The surgeon revised the tray, femur and insert to a gmk-revision system to give the patient more stability.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.3L
• 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: 23579774
• Report Number: 3005180920-2025-01105
• Device Sequence Number: 9259742
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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 Model Number: 02.07.1203L
• Device Lot Number: 2236484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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: 72 YR
• Patient Sex: Female