InjuryKWH
RTS
Received Jun 10, 2025 · Event occurred Dec 20, 2022
Report 3011580264-2025-00007 · MDR key 22175234
Device
Generic name
Prosthesis, Toe, Constrained, Polymer, Product Code: Kwh
Manufacturer
In2bones UsaModel number
M40 SE020Catalog number
M40 SE020
Lot number
9JXJ40
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR · Male
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
PER A RETROSPECTIVE POST-MARKET STUDY, IT WAS DISCOVERED THAT THE DEVICE, M40 SE020, RTS LESSER MTP IMPLANT, SIZE 2, WAS INITIALLY IMPLANTED ON (B)(6) 2022. IT WAS REPORTED THAT DUE TO AN INFECTION FROM THE IMPLANT A SECONDARY PROCEDURE WAS REQUIRED TO REMOVE THE DEVICE. THE COMPLICATION WAS SOLVED BY REMOVAL OF THE IMPLANT AND CLEANING OF THE ARTICULATION AND IMPLANTING A NEW RTS LESSER IMPLANT.