Harmony 74016261Recalls & reported problems
Smith & Nephew, Inc. · UNIVERSAL INSERT SPACER SZ 1-2 12MM · Class 2
All models of Harmony (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556746806), received between Sep 12, 2022 and Oct 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 12MM HAD AN UNSPECIFIED ISSUE WHICH IS POTENTIALLY RELATED TO DEVICE FRACTURE AS PIECES WERE REPORTEDLY RETRIEVED. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING AN EQUIVALENT S+N BACKUP DEVICE. NO INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364243 ↗MalfunctionSep 12, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 1-2 12MM BROKE IN HALF. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15407862 ↗
Other Trousers, anti-shock devices
- PENDING MMPF1110TMedline Industries, Inc. · Trousers, anti-shock2 reports
- PROPHECY INBONE PTA00050Wright Medical Technology, Inc. · Trousers, anti-shock1 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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