LEGION 71425207Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556108550), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K091543, 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.

• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY WAS PERFORMED ON (B)(6) 2023, A STERILE JOINT PUNCTURE WAS PERFORMED ON (B)(6) 2024 DUE TO A SUSPECTED INFECTION ON THE LEFT KNEE. THE INFECTION WAS DIAGNOSED ON (B)(6) 2024, AND AN OPEN BIOPSY WAS PERFORMED ON (B)(6) 2024. FINALLY, ON (B)(6) 2024, THE PATIENT REQUIRED A TOTAL REVISION SURGERY AND LONG-TERM ANTIBIOTICS TO ADDRESS THE ADVERSE EVENT. THE PATIENT IS STILL RECOVERING.

  Patient problems: Medical device site infection

  MAUDE report 21434536 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091543, 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