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

Model Number	1801-2140
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect - clinical code (e): clinical code 2646 "inadequate osseointegration" chosen as it was the closest to the intended code of 4883 "aseptic loosening".Intended code was not recognized by the system thus alternative code was selected.As part of the investigation, images of the patient's ankle at the time of the original surgery and now were reviewed for potential cause for the reported tibial implant loosening.In the images, it appears that bone cement was not used on the bone contacting surface of the implant, although the device is only indicated for use with cement, per lbl-50013 ifu -kinos tar.Bone cement is used to securely affix the implant to the bone; without it, there is potential risk of implant loosening, as seen reported in the complaint.Based on the investigation, the are no deficiencies with the design or risk considerations of the implant or the ability of the plasma spray/bone cement combination to provide secure fixation to the distal tibia.
Event or Problem Description
Tibial implant loosening on a total ankle replacement which is 3 years old requiring revision of the tibial implant.The loosening recently appeared and other than that the patient is doing well.

• Brand Name: KINOS AXIOM TOTAL ANKLE REPLACEMENT SYSTEM
• Common Device Name: TOTAL ANKLE
• 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: 20206173
• Report Number: 3014833750-2024-00001
• Device Sequence Number: 20743974
• Product Code: HSN
• UDI-Device Identifier: 00850022178122
• UDI-Public: 00850022178122
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 1801-2140
• Device Lot Number: 2008023
• 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: Not provided
• Initial Report FDA Received Date: 09/12/2024
• 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: 54 YR
• Patient Sex: Male