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MODULAR RAIL SYSTEM 71934154Recalls & reported problems

Smith & Nephew, Inc. · SMALL RAIL KNEE HINGE ASSY · Class 2 · Implant

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 00885556143322), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Twisted/Bent1

Patient problems

  • Failure of Implant1
  • 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.

  • MalfunctionApr 21, 2023Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING LENGTHENING OF FEMUR, A SMALL RAIL KNEE HINGE ASSY HAS BEEN BENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

    Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16792450 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.