LEGION 71421806Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010545404), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K041106, K230653); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING A TKA REVISION SURGERY, TWO (2) LGN POS FEM WDG 10MM SZ5-6 LNG WERE OPENED BUT THE SCREWS WERE TOO SHORT TO BE USED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041106, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-0092-2018 · Sep 14, 2017 · Terminated
  smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid