LEGION 71425004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010580320), received between Jan 20, 2023 and Oct 24, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN 2010 DUE TO BEARING WEAR AND OSTEOLYSIS. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. ON (B)(6) 2011, THE PATIENT SUSTAINED A FRACTURE. IT IS UNKNOWN WHAT ACTIONS WERE TAKEN TO ADDRESS THIS ISSUE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 20524067 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A LEFT TKA TWO-STAGE REVISION DUE TO AN UNKNOWN DIAGNOSIS. APPROXIMATELY EIGHTY FOUR (84) MONTHS AFTER THIS PROCEDURE, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE REVISED KNEE PROSTHESIS AND REQUIRED A SECOND REVISION. THE DATES IN WHICH THE INDEX SURGERY, FIRST TWO-STAGE REVISION AND SECOND REVISION TOOK PLACE ARE NOT KNOWN. IT IS ALSO UNKNOWN WHICH DEVICES WERE EXPLANTED AND/OR EXCHANGED DURING THE SECOND REVISION. THIS INCIDENT WAS IDENTIFIED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING TKA REVISION OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16216361 ↗

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-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.
• 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.