LEGION 71424026Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010546661), received between Dec 10, 2018 and Jun 2, 2020 — classified as 2 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K072531, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO POOR RANGE OF MOTION. SIGNIFICANT SOFT TISSUE WAS REMOVED. GOOD RANGE OF MOTION AT THE END OF THE SURGERY.

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion

  MAUDE report 10111012 ↗
• InjuryDec 10, 2018Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO JOINT INSTABILITY.

  Patient problems: Injury

  MAUDE report 8147215 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072531, 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