LEGION 71424045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010546777), received between Feb 9, 2020 and Sep 27, 2023 — classified as 2 injuries.

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.

• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TIBIAL REVISION SURGERY PERFORMED APPROXIMATELY 3 TO 5 YEARS AGO, THE PATIENT EXPERIENCED STIFFNESS AND TIBIAL PAIN. ANOTHER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT, REPLACING WITH ANOTHER LEGION REVISION AND SHORTER TIBIAL STEM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Loss of Range of Motion

  MAUDE report 17824644 ↗
• InjuryFeb 9, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS. NO PATIENT RECORDS, EXPLANTS, AND X-RAYS ARE AVAILABLE.

  Patient problems: No Information

  MAUDE report 9685307 ↗

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