LEGION 71421276Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556234259), received between Feb 18, 2019 and Nov 5, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryNov 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR, THE PATIENT PRESENTED WITH REDUCED RANGE OF MOTION. THE IMPLANT HAD BEEN IN SITU FOR YEARS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE AND REPLACE A GNS II CMT TIB SIZE 4 {} RIGHT, A LGN PS HIGH FLEX XLPE SZ 3-4 10MM AND A LEGION NARROW PS OXIN SZ 6N RT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 15740876 ↗
• MalfunctionApr 19, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING TKA REVISION SURGERY, THE LEGION NARROW PS OXIN SZ 6N RT DID NOT FIT ONTO THE BONE. AFTER THE CASE, IT WAS DISCOVERED THAT A JOURNEY II FEMUR WAS IN THE IMPLANT BOX. A SMITH AND NEPHEW BACKUP DEVICE FROM ANOTHER LOT WAS USED. SURGERY WAS DELAYED 15 MIN AS A CONSEQUENCE OF THIS PROBLEM. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149717 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A SILENT STROKE AND WAS ADMITTED TO THE HOSPITAL. SHE SUFFERED OF PAIN, SWELLING AND DISCOMFORT FOR SOME WEEKS. SHE HAD VARIOUS TESTING AND PROCEDURES SINCE THAT, AND SHE REQUESTED SOMETHING FOR PAIN CONTROL.

  Patient problems: Injury; Pain

  MAUDE report 8348514 ↗

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