LEGION 71421255Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556233801), received between Jan 3, 2019 and May 18, 2022 — classified as 2 injuries.

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 (K112941, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA ON (B)(6) 2019, THE FEMUR HAD A STREAK DOWN AT THE MEDIAL CONDYLE AND THE LGN XLPE CR INSERT SZ 1-2 9MM WAS BROKEN. THE PATIENT REQUIRED A REVISION SURGERY AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14429935 ↗
• InjuryJan 3, 2019Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT PATIENT IS SUFFERING FROM COMPLICATIONS FOLLOWING THE IMPLANTATION OF PROSTHESIS. NO PROCEDURE REPORTED TO REMEDIATE ADVERSE EVENT.

  Patient problems: Injury

  MAUDE report 8213634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112941, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0282-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
• 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-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5