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

Model Number	1831.1120
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Limb Pain (4836); Aseptic loosening (4883)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tibia is loosening most likely due to the fact that the implant was not properly seated or patient factors such as bone quality or likelihood of ingrowth.During the initial surgery, it was noted that there was difficulty seating the implant fully, which may have been due to improper surgical technique or patient bone being too hard, among many other possible causes.Improper seating can contribute to lack of ingrowth and subsequent loosening.Analysis of production records reveals no abnormailities that could contribute to this adverse event.
Event or Problem Description
Surgeon reported the patient's tibial implant shows signs of loosening and that they feel pain in the affected joint.After a scope procedure and checking for soft tissue impingement, the patient will be converted to a revision tibial and talar implant.

• Brand Name: KINOS TOTAL ANKLE SYSTEM
• Common Device Name: TOTAL ANKLE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 22729079
• Report Number: 3014833750-2025-00012
• Device Sequence Number: 20918876
• Product Code: HSN
• UDI-Device Identifier: 00840097505060
• UDI-Public: 00840097505060
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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
• Device Model Number: 1831.1120
• Device Lot Number: 2022100034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2022
• 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: 67 YR
• Patient Sex: Female