LEGION 71934056Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556143452), received between Mar 10, 2020 and Oct 9, 2025 — classified as 3 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K100897, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2015, PATIENT COMPLAINT OF LEFT KNEE PAIN. PATIENT WAS SEEN IN CLINIC AND FOUND TO HAVE OSTEOARTHRITIS OF THE LEFT KNEE IN THE PATELLOFEMORAL ARTICULATION. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH THE LEGION POROUS HA TIBIAL BASE SZ 4 LT WAS EXCHANGED. PATIENT'S OUTCOME WAS RECOVERED.

  Patient problems: Arthritis

  MAUDE report 23263123 ↗
• InjuryOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED PAIN AND WAS FOUND TO HAVE A SEVERE PATELLOFEMORAL OSTEOARTHRITIS IN THE LEFT KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LEGION POROUS HA TIBIAL BASE SZ 4 LT WAS REVISED. THE ADVERSE EVENT WAS RESOLVED. THIS ADVERSE EVENT WAS IDENTIFIED DURING A CLINICAL STUDY.

  Patient problems: Arthritis; Erosion; Pain

  MAUDE report 23251605 ↗
• InjuryMar 10, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT PRESENTED ASEPTIC LOOSENING ON THE TIBIAL BASEPLATE OF THE LEFT KNEE. THIS WAS NOTICED WHEN THE RADIOGRAPHIC IMAGES SHOWED RADIOLUCENCIES ON THAT COMPONENT. IT IS UNKNOWN HOW THE COMPLICATION WAS TREATED.

  Patient problems: Injury

  MAUDE report 9814225 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100897, 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