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	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 november 2025.Gmk-spherika 02.07.1203l tibial tray fix cemented s.3l (k090988) lot 2421612: (b)(4) items manufactured and released on 13-jan-2025.Expiration date: 08-dec-2029.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.Clinical evaluation: a revision surgery was performed approximately eight months after the primary tka due to component malpositioning.Based on the available x-ray, the femoral component appears to be positioned in slight flexion, resulting in anterior femoral lift-off.Additionally, the patella shows noticeable tilt and some degree of deformation.These factors may have contributed to abnormal patellar tracking and the patient’ s reported symptoms.No significant malpositioning of the tibial component is appreciable (at most, only a slight increase in posterior slope).Given that the issue is related to malpositioning, there is no evidence to suggest a device defect.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
At about 8 months from the primary was performed a total knee revision due to malposition of the tibia.Excessive external rotation.The surgeon decided to remove everything and implant a semi-constrained prosthesis.

• 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: 23838592
• Report Number: 3005180920-2025-01238
• Device Sequence Number: 9607425
• 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: 2025
• 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): 12/18/2025

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: 2421612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2025
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White