LEGION 71423243Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556030707), received between Dec 17, 2024 and Dec 17, 2024 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K073325, 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.

• InjuryDec 17, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2022, THE PATIENT PRESENTED A NICKEL ALLERGY. THIS WAS ADDRESSED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2024 TO EXCHANGE A LGN POROUS CR FEM SZ 3L AND A LGN CRHF XLPE INS W/JRNY LCK SZ 1-2 10MM. CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20952401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073325, 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