MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIXED CEMENTED SIZE 6 R

Model Number	02.07.1206R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2025.Lot 2502698: (b)(4) items manufactured and released on 07-july-2025.Expiration date: 2030-06-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation: a revision surgery was performed approximately 3 months after implantation of a tka due to a periprosthetic tibial fracture.The available radiographic images are of very poor quality; however, a collapse of the medial tibial plateau can be identified.During the revision procedure, an area of compromised bone quality was reportedly observed beneath the tibial tray and was attributed to metastatic disease.If confirmed, this finding would be consistent with a pathological fracture and could explain the occurrence of the fracture in the absence of any reported traumatic event.There is no evidence to support an implant defect or device malfunction.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
Revision surgery due to tibial loosening secondary to periprosthetic fracture at about 3 months after the primary surgery.Presence of a particular tissue under the tibial tray with poor bone quality.Explantation of tibial tray and insert.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIXED CEMENTED SIZE 6 R
• 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: 24020872
• Report Number: 3005180920-2026-00011
• Device Sequence Number: 15695711
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• 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): 01/09/2026

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: 02.07.1206R
• Device Lot Number: 2502698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2025
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 110 KG