LEGION 71423213Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556029428), received between Apr 23, 2021 and Sep 18, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K060742, 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 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2024, THE PATIENT PRESENTED RIGHT LOWER LOBE PNEUMONIA SINCE (B)(6) 2024. EVENT WAS INDICATED TO BE POSSIBLY RELATED TO THE PROCEDURE. ACTIONS TAKEN FOR THE ADVERSE EVENT WERE MEDICATION AND THERAPY DURING A PROLONGED HOSPITALIZATION. PATIENT IS CURRENTLY RECOVERING FROM THE ADVERSE EVENT.

  Patient problems: Pneumonia

  MAUDE report 20247072 ↗
• InjuryApr 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING TKA SURGERY, BOTH POROUS AND NON-POROUS COMPONENTS WERE PREPARED FOR THE PROCEDURE, THEN, THE CUSTOMER MISTOOK NON-POROUS COMPONENT FOR POROUS ONE, AND THE LEGION CR NP FEM SIZE 3 RIGHT WAS IMPLANTED WITHOUT BONE CEMENT. THERE WAS NO SURGICAL DELAY. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720938 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060742, 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-0590-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0589-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0591-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.