LEGION 71423214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556029930), received between Aug 24, 2019 and Feb 17, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED CONSTIPATION AND POST-OPERATIVE ANEMIA. THE ANEMIA WAS TREATED WITH 1 UNIT OF RBC AND THE CONSTIPATION WITH DOCUSATE SODIUM 50 MG + SENNOSIDE B 8 MG TABLET. THE PATIENT RECOVERED.

  Patient problems: Anemia; Constipation

  MAUDE report 16400982 ↗
• InjuryOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT TWO DAYS AFTER PRIMARY KNEE REPLACEMENT DISCHARGE, PATIENT RETURNED TO THE HOSPITAL WITH SURGICAL INFECTION WITH FOLLOW-UP OF 8 DAYS OF HOSPITALIZATION.

  Patient problems: Unspecified Infection

  MAUDE report 9216049 ↗
• InjuryAug 24, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT HAD PRIMARY SURGERY IN 2018 AND ITS COMPONENTS ARE LOOSE BUT NO REVISION SURGERY HAS BEEN PERFORMED.

  Patient problems: Injury

  MAUDE report 8928683 ↗

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-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.
• 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-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.