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Harmony 74016232Recalls & reported problems

Smith & Nephew, Inc. · EM TIBIAL ALIGNMENT TUBE MACRO · Class 1

All models of Harmony (25)

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 00885556735480), received between May 6, 2021 and May 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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.

  • MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIN OF A EM TIBIAL ALIGNMENT TUBE MACRO LOOSENED AND COMPLETELY FELL OUT. THIS WAS NOTICED AFTER THE PROXIMAL TIBIA CUT WAS MADE AND THE INSTRUMENT WAS LAID ON A BACK TABLE. IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY IN SURGERY, AND IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO PATIENT INJURY WAS REPORTED. NO OTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11781866 ↗

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Sources and updates

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