MAUDE Adverse Event Report: RESTOR3D, INC. KINOS AXIOM TOTAL ANKLE SYSTEM; TOTAL ANKLE ARHTROPLASTY

Model Number	1801.1141
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Engineer noted while planning for a revision case that the implant to be revised was a legacy kinos axiom tibial implant component that had become loose.The operating surgeon noted that the patient has joint instability and a fracture of the medial malleolus that contributed to the implant loosening, rather than any obvious defect of the implant itself.
Additional Manufacturer Narrative
The device has not been received for evaluation by the manufacturer.Review of production records reveals no abnormalities that would have any impact on construct stability of the tar system.The operating surgeon has evaluated the patient and assessed that the adverse event is related to the patient factors such as joint instability and a fracture of the distal tibia, rather than any defect of the implant components.
Event or Problem Description
Engineer noted while planning for a revision case that the implant to be revised was a legacy kinos axiom tibial implant component that had become loose.The operating surgeon noted that the patient has joint instability and a fracture of the medial malleolus that contributed to the implant loosening, rather than any obvious defect of the implant itself.
Additional Manufacturer Narrative
The device has not been received for evaluation by the manufacturer.Review of production records reveals no abnormalities that would have any impact on construct stability of the tar system.The operating surgeon has evaluated the patient and assessed that the adverse event is related to the patient factors such as joint instability and a fracture of the distal tibia, rather than any defect of the implant components.

• Brand Name: KINOS AXIOM TOTAL ANKLE SYSTEM
• Common Device Name: TOTAL ANKLE ARHTROPLASTY
• Manufacturer (Section D): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 22207017
• Report Number: 3014833750-2025-00009
• Device Sequence Number: 12453805
• Product Code: HSN
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K192778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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
• Device Expiration Date: 05/01/2024
• Device Model Number: 1801.1141
• Device Lot Number: 2105004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male