FDA Adverse Event
Injury
Summary report: N
KINOS AXIOM TOTAL ANKLE REPLACEMENT
MDR report key: 23730303
·
Received December 5, 2025
Report
- Report Number
- 3014833750-2025-00020
- Event Type
- Injury
- Date Received
- December 5, 2025
- Report Date
- December 4, 2025
- Manufacturer
- RESTOR3D, INC.
- Product Code
- HSN
- UDI-DI
- 00850022178009
- PMA / PMN Number
- K192778
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
REVIEW OF PRODUCTION RECORDS REVEALS NO NONCONFORMANCES ASSOCIATED WITH THE PRODUCTION OF THE COMPONENT IN QUESTION. PATIENT FACTORS ARE UNABLE TO BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. LACK OF PRODUCTION ABNORMALITIES INDICATES THERE WAS NO DEVICE DEFECT LEADING TO THE NEED FOR REVISION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOOSENING OF THE TIBIAL COMPONENT OF THEIR TOTAL ANKLE REPLACEMENT AND THAT THE TALAR COMPONENT HAD SUBSIDED DUE TO POOR BONE QUALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2884540 | KINOS AXIOM TOTAL ANKLE REPLACEMENT | TOTAL ANKLE REPLACEMENT | HSN | RESTOR3D, INC. | 1801.1110 | 00850022178009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |