LEGION 71421246Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556233603), received between Sep 24, 2020 and Sep 24, 2020 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K112941, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO SEVERE LEFT KNEE STIFFNESS AND PAIN IN THE PATIENT. THE TIBIAL INSERT WAS REVISED AND EXPLANTED FROM THE PATIENT. THE PATIENT IS STILL RECOVERING FROM THE SURGERY. INITIAL SURGERY IN THE LEFT KNEE WAS PERFORMED ON (B)(6) 2015. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Loss of Range of Motion; Pain

  MAUDE report 10583539 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112941, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0282-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
• 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-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5