RTS M40 SE020Recalls & reported problems
In2Bones USA, LLC · RTS LESSER MTP IMPLANT, SIZE 2 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817906024296), received between Apr 30, 2025 and Aug 27, 2025 — classified as 3 injuries.
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 Problem3
Patient problems
- Implant Pain1
- Insufficient Information1
- Joint Dislocation1
- Post Operative Wound Infection1
- Swelling/ Edema1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, IN2BONES USA WAS INFORMED THAT THE DEVICE, M40 SE020, RTS LESSER MTP IMPLANT, SIZE 2, WAS INITIALLY IMPLANTED ON (B)(6) 2024 AND IT WAS REPORTED THAT DUE TO IMPLANT BREAKAGE A SECONDARY PROCEDURE HAS BEEN SCHEDULED FOR (B)(6) 2025. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF SECONDARY SURGERY FOR THE REMOVAL OF THE IMPLANT.
Patient problems: Implant Pain; Insufficient Information; Swelling/ Edema
MAUDE report 22903835 ↗InjuryJun 10, 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 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.
Patient problems: Post Operative Wound Infection
MAUDE report 22175234 ↗InjuryApr 30, 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 SE020, RTS LESSER MTP IMPLANT, SIZE 2, WAS INITIALLY IMPLANTED ON (B)(6) 2024 AND IT WAS REPORTED DUE TO IMPLANT DISLOCATION, A SECONDARY PROCEDURE ON (B)(6) 2025 WAS REQUIRED TO REMOVE THE DEVICE. THE COMPLICATION WAS SOLVED BY REMOVAL OF THE IMPLANT. FURTHER ASSESSMENT INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF SECONDARY SURGERY FOR REMOVAL OF AN IMPLANT.
Patient problems: Joint Dislocation
MAUDE report 21934659 ↗
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- 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
- SWANSON G4260102Wright Medical Technology, Inc. · PROSTHESIS, TOE, CONSTRAINED, POLYMER2 reports
- SWANSON G4260001Wright Medical Technology, Inc. · PROSTHESIS, TOE, CONSTRAINED, POLYMER1 report
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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