LEGION 71423223Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010611406), received between Nov 4, 2021 and Nov 4, 2021 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA SURGERY DUE TO DUE TO "RHEUMATOID ARTHRITIS (DOUBLE KNEE DISEASE)". IT WAS PERFORMED ON (B)(6) 2021, EIGHTS DAYS AFTER THE TKA, THE PATIENT DEVELOPED LEFT KNEE PAIN AND LIMITED ACTIVITY AFTER REHABILITATION EXERCISE AT HOME. PATIENT CONTINUED TO CARRY OUT FUNCTIONAL EXERCISE, AND THE PAIN TENDED TO WORSEN WITHOUT RELIEF AFTER REST. THE FILM TAKEN IN THE LOCAL HOSPITAL SHOWED A FRACTURE AROUND THE LEGION PS NP FEM SZ 3 LT PROSTHESIS THAT WAS TREATED CONSERVATIVELY WITH PLASTER. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 FOR FURTHER TREATMENT. CURRENT HEALTH STATUS OF PATIENT IS IN GOOD CONDITION AND OUT OF THE HOSPITAL.

  Patient problems: Bone Fracture(s); Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 12752003 ↗

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-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-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.