InjuryKWH
RTS LESSER
Received Oct 16, 2025 · Event occurred Aug 5, 2024
Report 3011580264-2025-00012 · MDR key 23316698
Device
Generic name
Prosthesis, Toe, Constrained, Polymer
Manufacturer
In2bones UsaModel number
M40 SE030Catalog number
M40 SE030
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Osteolysis
- Implant Pain
- Osteolysis
- Implant Pain
Narrative
Description of Event or Problem
PER A RETROSPECTIVE POST-MARKET STUDY, IT WAS DISCOVERED THAT THE DEVICE, M40 SE030, RTS LESSER MTP IMPLANT, SIZE 3, WAS INITIALLY IMPLANTED ON (B)(6) 2024 AND IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL OSTEOLYSIS AROUND THE BASE OF THE IMPLANT. THE IMPLANT WAS REMOVED ON (B)(6) 2024 AND REPLACED WITH BONE GRAFTING.