SWANSON G4260001Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
All models of SWANSON (12)
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 00840420127402), received between Feb 13, 2026 and Feb 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
Patient problems
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2026Fracture
IT WAS REPORTED THAT "ON REMOVAL IT WAS NOTICED THAT THE DEVICE WAS BROKEN. IT WAS TORN DOWN ONE SIDE.PATIENT EXPERIENCED SEVERE PAIN IN THE JOINT, REQUIRING HIGH DOSES OF ANALGESIA, INTENSE PHYSIO AND A DIAGNOSIS OF COMPLEX REGIONAL PAIN SYNDROME (CRPS). JOINT SWELLING CONSTANTLY AND PATIENT WAS IN CONSTANT PAIN. BECAUSE OF SEVERE PAIN, PATIENT WAS INVESTIGATED FOR OSTEOMYELITIS. THIS DEFECT WAS NOT PICKED UP ON MAGNETIC RESONANCE IMAGING (MRI) OR X-RAYS."
Patient problems: Pain; Swelling/ Edema
MAUDE report 24333114 ↗
Other PROSTHESIS, TOE, CONSTRAINED, POLYMER devices
- Taperloc Complete Micro Primary Femoral 51-109070Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER24 reports
- Taperloc Complete Micro Primary Femoral 51-106100Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER13 reports
- 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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