LEGION 71423218Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556030165), received between Feb 18, 2019 and Jun 11, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT IS EXPERIENCING SEVERE MUSCLE PAIN SINCE (B)(6) 2023. EVEN WHEN A PUNCTURE WAS PERFORMED 3 WEEKS AFTER SURGERY, THE KNEE IS STILL SWOLLEN. IT IS UNKNOWN IF AN ADDITIONAL INTERVENTION WAS DONE.

  Patient problems: Inflammation; Myalgia; Pain

  MAUDE report 19510465 ↗
• InjuryNov 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INITIAL TKA PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT FIRST-STAGE REVISION SURGERY DUE TO INFECTION. AN ANTIBIOTIC SPACER WAS PLACED AS PART OF THIS PROCEDURE. ALL IMPLANTS WERE REVISED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15862875 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FLUOROSCOPICALLY GUIDED RIGHT TOTAL KNEE ARTHROPLASTY ASPIRATION WAS PERFORMED DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8348877 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO CONSISTENT PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8348874 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN ARTHROCENTESIS OF RIGHT KNEE DUE TO CHRONIC PAIN.

  Patient problems: Pain

  MAUDE report 8348424 ↗

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-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.
• 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.