LEGION 71423215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556030158), received between Feb 23, 2023 and Mar 20, 2024 — classified as 2 injuries.

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

• InjuryMar 20, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT RIGHT TKR SURGERY ON (B)(6) 2023 DUE TO ARTHROSIS, IN WHICH A GNS II CMT TIB SIZE 3 RIGHT, A GII DISHED INS SZ 3-4 13MM AND A LEGION CR NP FEM SZ 5 RT WERE IMPLANTED, SHE HAS BEEN EXPERIENCING A LOT OF SWELLING AND LACK OF FLEXION 4 MONTHS POST-SURGERY. THE PATIENT'S KNEE BECOMES IRRITATED AND SWOLLEN EVEN WITH THE SIMPLEST OF EXERCISES (NON-STRESS WEIGHT BEARING, STRETCHING ONLY). THE PATIENT HAS BEEN SUFFERING FROM DAILY BOUTS OF INFLAMMATION, FLUID RETENTION IN HER LEG, AND THE JOINT BECOMES VERY HOT WHILST SWOLLEN. X-RAYS REVEALED DEGENERATIVE CHANGE WITH LOSS OF JOINT SPACE, OSTEOPHYTIC LIPPING AND SMALL JOINT EFFUSION. THE PATIENT CLAIMS TO BE ALLERGIC TO METAL AND MADE THE ASSUMPTION THAT THE IMPLANTED SYSTEM WOULD BE HYPOALLERGENIC. IN ADDITION, SHE STATED SHE WAS NEVER ASKED ABOUT HER MEDICAL HISTORY BEFORE TKR WAS CONDUCTED. DERMATOLOGIC TEST IS STILL PENDING. NO FURTHER INTERVENTIONS HAVE BEEN SCHEDULED AT THIS TIME AND THE PATIENT IS CURRENTLY TAKING CETIRIZINE AND 2 X 500MG IBUPROFEN EVERY DAY.

  Patient problems: Ankylosis; Inflammation; Joint effusion; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 18946965 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT HAD AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WHERE THE PATIENT HAD A KNEE WASHOUT AND ALL THE IMPLANTS WERE REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16432257 ↗

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.