EVOS 72453106Recalls & reported problems
Smith & Nephew, Inc. · EVOS 3.5MM PARTIAL ARTICULAR LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM · Class 2 · Implant
All models of EVOS (190)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556640319), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE 3.5 LOCKING SCREW WAS INSERTED INTO A LOCKING SCREW HOLE AND PASSED ALL THE WAY THROUGH THE EVOS 3.5MM P/A L-P TIBIA PL 6H L 91MM. THE HOLE IN QUESTION HAD PREVIOUSLY BEEN USED TO COMPRESS THE PLATE TO BONE WITH A CORTICAL SCREW. THE SCREW WAS THEN TRAPPED BENEATH THE PLATE AND NOT REMOVED, IT WAS LEFT IN THE PATIENT. THE PROCEDURE CONTINUED ON WITHOUT FURTHER DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21228885 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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