UNKNOWN APEX 3D TIBIAL COMPONENT
Received Feb 23, 2026 · Event occurred Aug 6, 2025
Report 3008650117-2026-00049 · MDR key 24415627
Device
Generic name
Apex 3d Total Ankle Replacement System
Manufacturer
Paragon 28Catalog number
UNKNOWN TIBIAL COMPONENT
Lot number
UNKNOWN
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Male
- Implant Pain
Narrative
Additional Manufacturer Narrative
(B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A REVISION OF A TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT WAS CONDUCTED DUE TO PAINFUL COMPONENT LOOSENING 14 MONTHS POST IMPLANTATION. THE REPORTER PROVIDED X-RAYS. THE PATIENT IS CURRENTLY WITHOUT PAIN POST REVISION. NO OTHER TREATMENT OR INTERVENTION WAS REPORTED. NO ENVIRONMENTAL CONDITIONS OR CONTRIBUTING FACTORS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.