Legion 71935386Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556645383), received between Oct 28, 2019 and Oct 28, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K162775, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR PAIN AND INFLAMMATION. IT WAS DISCOVERED THAT THE PATIENT HAD AN INFECTION. ALL COMPONENTS WERE REVISED EXCEPT FOR THE PATELLA. THE PATIENT HAD UNDERGONE A WASHOUT A YEAR PRIOR TO THIS REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 9247986 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162775, 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-2624-2017 · May 30, 2017 · Terminated
  LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
• Z-2625-2017 · May 30, 2017 · Terminated
  LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM