MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; TIBIAL TRAY FIXED CEMENTED SIZE 5+ L

Model Number	02.07.12055L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to pain related to patella bone tracking issues.Additionally, the surgeon believes the patient's mcl was damaged in a fall.At about 4 months post primary the surgeon revised the knee to a hinge system (femur, tibia, and insert), resurfaced the patella.The surgery was completed successfully.The maltracking could be related to the fall but it is not confirmed.
Additional Manufacturer Narrative
Batch reviews performed on 13 october 2025: gmk-spherika 02.07.12055l gmk fixed tibial tray cemented 5+ left (k211004) lot 2409717: 30 items manufactured and released on 04-sep-2024.Expiration date: 2024-sep-04.No anomalies found related to the problem.To date, 19 items of the same lot have been sold with no similar reported event during the period of review.Additional component involved and revised: batch reviews performed on 13 october 2025: gmk-spherika 02.12.E0510fl gmk-sphere tibial insert e-cross - flex 5l - 10mm (k202022) lot 2433530: 50 items manufactured and released on 18-dec-2024.Expiration date: 2029-dec-04.No anomalies found related to the problem.To date, 46 items of the same lot have been sold with no similar reported event during the period of review.Batch reviews performed on 13 october 2025: gmk-spherika 02.12.Ka07l gmk spherika femoral component s7l cemented (k211004) lot 2404724: 36 items manufactured and released on 06-aug-2024.Expiration date: 2029-jul-17.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported event during the period of review.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.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIXED CEMENTED SIZE 5+ L
• 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: 23356479
• Report Number: 3005180920-2025-01045
• Device Sequence Number: 15671416
• Product Code: JWH
• UDI-Device Identifier: 07630345729583
• UDI-Public: 07630345729583
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 02.07.12055L
• Device Lot Number: 2409717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 61 YR
• Patient Sex: Male