LEGION 71423205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556029442), received between Aug 14, 2020 and Nov 26, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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.

• InjuryNov 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TWO STAGE TKA LEFT REVISION SURGERY IN 2019 DUE TO INFECTION. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.15 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. 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: Insufficient Information

  MAUDE report 20789152 ↗
• MalfunctionAug 14, 2020Defective Device; Connection Problem; Defective Device; Connection Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FEMORAL COMPONENT DID NOT CONTAIN PEGS, FOR THAT REASON THE DEVICE WAS NOT INSERTED. THEREFORE, AN OXINIUM FEMORAL (SIZE 5) BACKUP WAS USED TO FINISH THE PROCEDURE. THERE WAS A DELAY BETWEEN 0-30MIN.

  Patient problems: Foreign Body In Patient; No Information

  MAUDE report 10411379 ↗

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.