LEGION 71425215Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556108505), received between Jun 11, 2023 and Oct 31, 2025 — classified as 4 injuries.

1 other recall cover devices cleared under the same FDA submission (K091543, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED ARTHROFIBROSIS OF THE RIGHT KNEE. THIS ADVERSE EVENT WAS TREATED WITH MANIPULATION OF RIGHT KNEE (MUA) ON (B)(6) 2023. THE CURRENT OUTCOME AND THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 23437838 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED KNEE STIFFNESS. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING MANIPULATION UNDER ANESTHESIA. PATIENT'S CURRENT HEALTH STATUS IS RECOVERED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 18983947 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A RIGHT IMPENDING KNEE CONTRACTURE. THIS ADVERSE EVENT WAS DIAGNOSED, BY A CLINICAL STUDY ON (B)(6) 2024. THE ISSUE WAS TREATED ON (B)(6) 2024 VIA MANIPULATION UNDER ANESTHESIA. PATIENT'S OUTCOME IS ONGOING.

  Patient problems: Loss of Range of Motion

  MAUDE report 18717639 ↗
• InjuryJun 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2023 WITH A JOURNEY/LEGION SYSTEM, THE PATIENT PRESENTED MODERATE STIFFNESS ON THE RIGHT KNEE ON (B)(6) 2023. THIS ADVERSE EVENT WAS TREATED WITH PROCEDURE/SURGERY (KNEE MANIPULATION) ON (B)(6) 2023. THIS ADVERSE EVENT IS ONGOING. PATIENT CURRENT HEALTH STATUS IS RECOVERING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 17102355 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091543, 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