ENDO-FUSE 500004945Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
Data updated Oct 18, 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 00840420140920), received between May 20, 2022 and May 20, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Deformity/ Disfigurement1
- Implant Pain1
- Subluxation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY IN 2014. IT IS NOW BELIEVED THAT THE PATIENT MAY HAVE A BROKEN DEVICE AND IS IN PAIN AND THE ANKLE IS DEFORMED. THE DOCTOR RECOMMENDED NOT DOING ANYTHING DUE TO RISK OF INFECTION AND AMPUTATION IF THERE IS AN ISSUE.
Patient problems: Deformity/ Disfigurement; Implant Pain; Subluxation
MAUDE report 14462837 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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