MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.2L

Model Number	02.07.1202L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 march 2026.Gmk-spherika 02.07.1202l tibial tray fix cemented s.2l ((b)(6)) lot 2346730: (b)(4) items manufactured and released on 09-apr-2024.Expiration date: 14-mar-2029.No anomalies found related to the problem.To date, 54 items of the same lot have been sold with no similar reported event during the period of review.Gmk-spherika 02.12.Ka03l gmk spherika femoral component s3l cemented ((b)(6)) lot 2402415: (b)(4) items manufactured and released on 25-jun-2024.Expiration date: 10-jun-2029.No anomalies found related to the problem.To date, 49 items of the same lot have been sold with no similar reported event during the period of review.Gmk-spherika 02.12.E0213fl gmk-sphere tibial insert e-cross - flex 2l - 13mm ((b)(6)) lot 2318201: 60 items manufactured and released on 09-aug-2023.Expiration date: 17-jul-2028.No anomalies found related to the problem.To date, 30 items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the available information, no definitive root cause can be established.There is no indication that a device-related issue caused or contributed to the event, and the device history record review did not identify any manufacturing-related issues.
Event or Problem Description
At about 1 year and 7 months from the primary, the patient came in due to signs of a metal allergy and the cause is unknown.The surgeon revised the gmk-spherika tray to a gmk-hinge tray, the gmk-spherika insert 13mm to a gmk-hinge 23mm insert, and the gmk-spherika femoral component to a gmk-hinge femoral component.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.2L
• 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: 24710827
• Report Number: 3005180920-2026-00260
• Device Sequence Number: 6110344
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/27/2026

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 Model Number: 02.07.1202L
• Device Lot Number: 2346730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2024
• 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