LEGION 71424027Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010546678), received between Feb 21, 2019 and Jan 19, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Missing Information” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE LABEL ON THE PACKAGING IS NOT COMPLIANCE. IT DOES NOT CONTAIN THE SKU NUMBER. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197333 ↗
• MalfunctionJan 19, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE LABEL ON THE PACKAGING IS NOT COMPLIANCE. IT DOES NOT CONTAIN THE SKU NUMBER. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197319 ↗
• MalfunctionJan 18, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE LABEL ON THE PACKAGING IS NOT COMPLIANCE. IT DOES NOT CONTAIN THE SKU NUMBER. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11188741 ↗
• InjuryFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FAILED PREVIOUS TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury

  MAUDE report 8359598 ↗

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