LEGION 71421808Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010545428), received between May 26, 2022 and May 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K041106, 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.

• MalfunctionMay 26, 2022Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT, WHEN FIXING THE POSTERIOR AUGMENT TO THE FEMUR, THE LGN POS FEM WDG 10MM SZ7-8 LNG DID NOT INTERLOCK WITH THE SCREW HOLE THREAD. THE SCREW COULD NOT BE TIGHTENED, AND GOT DEFORMED. AFTER SEVERAL ATTEMPTS, ANOTHER LGN POS FEM WDG 10MM SZ7-8 LNG WAS OPENED. UNFORTUNATELY, THIS COULD NOT BE FIXED TO THE FEMUR EITHER. THE AUGMENT HAD TO BE FIXED TO THE FEMUR WITH CEMENT. A NON-SIGNIFICANT DELAY OCCURRED AS A CONSEQUENCE OF THIS ISSUE. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14506326 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041106, 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-0092-2018 · Sep 14, 2017 · Terminated
  smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid