LEGION 71421245Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556233559), received between Jun 3, 2019 and May 28, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP, IT WAS NOTICED THAT THE PACKAGING OF THE LEGION NARROW CR OXIN SZ 5N LT WAS DAMAGED, IT WAS ALREADY OPEN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538237 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF LEGION PRIMARY CR PROSTHESIS WAS PERFORMED DUE TO MALROTATION FEMUR. THE LEGION NARROW CR OXIN SZ 5N LT WAS REVISED AND EXCHANGED. THE PATIENT WAS DISCHARGED FROM HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 11001986 ↗
• InjuryJun 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS IN THE LEFT KNEE. PATIENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA. THE EVENT WAS RESOLVED.

  Patient problems: Fibrosis

  MAUDE report 8663104 ↗

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