LEGION 71420959Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010555816), received between May 8, 2019 and Mar 4, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K230653, K962137); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) LEGION CON ART INS 9MM SZ 1-2 WAS COUPLED TO THE TIBIA CORRECTLY ACCORDING TO THE SURGICAL TECHNIQUE, AND WHILE TESTING THE FLEXION AND EXTENSION THE INSERT CAME OUT, SO AFTER TRYING FOR A LONG TIME AND IN EVERY WAY, THE INSERT WAS CHANGED BY A GENESIS II PRIMARY WITH THE SAME SIZE 1-2 9MM WHICH HAD NO ISSUE. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483390 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *LEGAL CASE* IT WAS REPORTED THAT, AFTER A PROSTHETIC RE-IMPLANT HAD OCCURRED ON (B)(6) 2018 WITH A LEGION KNEE SYSTEM, THE PATIENT STARTED EXPERIENCING PAIN. THE X-RAYS SHOWED THE FEMORAL AND THE TIBIAL STEMS WITH PHLOGOSIS. A REVISION SURGERY WAS NECESSARY TO REMOVE THE WHOLE SYSTEM AND REPLACED IT WITH CEMENT SPACERS ON (B)(6) 2021. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Inflammation

  MAUDE report 11806515 ↗
• InjuryMay 8, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEPTIC MOBILIZATION OF THE PROSTHESIS.

  Patient problems: Injury

  MAUDE report 8591283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230653, K962137. 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-0118-2021 · Sep 21, 2020 · Terminated
  Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e.