NA 76544151Recalls & reported problems
Smith & Nephew, Inc. · UNIV.TRIAL HEAD 36 MM 12/14 +0 · Class 1
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 03596010543424), received between Nov 2, 2020 and Nov 2, 2020 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2020Break; Break
IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS ATTEMPTING TO TRIAL THE HEAD AND IT WOULD NOT ATTACH TO THE TRIAL NECK. IT WAS FOUND THAT THE INNER PORTION OF THE TRIAL HEAD WAS BROKEN. THE CLIENT BELIEVES THAT IT HAPPENED DURING STERILIZATION, NOT DURING SURGERY. S&N BACKUP DEVICE AVAILABLE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10773147 ↗
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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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