LEGION 71423206Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556030035), received between May 18, 2021 and Aug 16, 2023 — classified as 2 injuries.

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.

• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CORI ASSISTED TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT HAD ONE EPISODE OF HYPOTENSION THE DAY AFTER THE OPERATION; THE PATIENT ALSO EXPERIENCED HYPOKALEMIA AND ACUTE KIDNEY INJURY; ADDITIONALLY, THERE WAS ALSO ONE EPISODE OF CHOKING REPORTED. THIS RESULTED IN A PROLONGED HOSPITALIZATION AND WAS RESOLVED VIA THE USE OF NALOXONE, FLUIDS AND RED BLOOD CELLS FOR THE HYPOTENSION; CHLORVESCENT MEDICATION AND AN IDC INSERTION FOR THE HYPOKALEMIA AND KIDNEY INJURY; LASTLY, THE PATIENT WAS PUT ON THIN FLUIDS/SOFT DYSPHAGIA DIET DUE TO THE CHOKING EPISODE. THE PATIENT'S STATUS WAS REPORTED AS RECOVERING.

  Patient problems: Choking; Hypokalemia; Low Blood Pressure/ Hypotension; Renal Failure; Renal Impairment

  MAUDE report 17557650 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RECON SURGERY HAD BEEN PERFORMED, THE PATIENT REPORTED AN INFECTION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE LGN CR HIGH FLEX XLPE SZ 5-6 10MM, GII LNG STEM 10MM X 100MM, GNS II CMT TIB SIZE 6 LEFT, LEGION CR NP FEM SZ 6 LT, AND GNS II RESURF PAT 35MM. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 11844828 ↗

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.