LEGION 71424093Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010592743), received between Jun 20, 2022 and Jun 20, 2022 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K072531, 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.

• InjuryJun 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA WAS PERFORMED ABOUT 6 YEARS AGO, THE PATIENT PRESENTED WITH A BROKEN LGN PRSFT STEM 20MMX220MM BWD WITH A LEGION REVISION KNEE IMPLANTED. THIS WAS ADDRESSED VIA REVISION SURGERY AND UPON OPENING THE KNEE, THE LGN PRSFT STEM 20MMX220MM BWD HAD BROKEN AT THE BOSS OF THE FEMORAL COMPONENT. THERE WAS NO FIXATION OF THE LEGION REVISION FEMUR TO THE PATIENTS BONE. DURING REVISION SURGERY, THE DEVICE WAS REMOVED. THE FEMORAL CANAL WAS GRAFTED BY IMPACTION AND A SHORTER STEM WAS CEMENTED IN PLACE WITH A NEW FEMORAL COMPONENT. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14742809 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072531, 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