RTS M40 SE030Recalls & reported problems
In2Bones USA, LLC · RTS LESSER MTP IMPLANT, SIZE 3 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817906024302), received between May 14, 2025 and May 14, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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) 2025. 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 M40 SE030, RTS LESSER MTP IMPLANT, SIZE 3.
Patient problems: Post Operative Wound Infection
MAUDE report 22017971 ↗
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- Taperloc Complete Micro Primary Femoral 51-109080Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER9 reports
- Taperloc Complete Micro Primary Femoral 51-106180Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER7 reports
- Taperloc Complete Micro Primary Femoral 51-108070Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER6 reports
- Taperloc Complete Micro Primary Femoral 51-106120Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER4 reports
- RTS M40 SE020In2Bones USA, LLC · Prosthesis, Toe, Constrained, Polymer3 reports
- SWANSON G4260102Wright Medical Technology, Inc. · PROSTHESIS, TOE, CONSTRAINED, POLYMER2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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