LEGION 71453261Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556255773), received between Dec 17, 2019 and Sep 4, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K071071, 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.

• InjurySep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED THE BREAKAGE OF THE INSERT POST. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LGN XLPE PS INSERT SZ 7-8 15MM WAS REVISED TO A NEW POLY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22963764 ↗
• InjuryApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED THROUGH A REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH THE POST OF THE LGN XLPE PS INSERT SZ 7-8 15MM WAS FOUND TO BE BUSTED OFF, THEREFORE IT WAS EXPLANTED AND CHANGED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16718661 ↗
• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2013, THE POST OF THE PATIENT ON THE POLYETHYLENE ARTICULAR INSERT WAS FOUND TO HAVE SHEARED OFF; BROKEN POST. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE LGN XLPE PS INSERT SZ 7-8 15MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14454873 ↗
• InjuryDec 17, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT REVISION OF A POLY INSERT WAS PERFORMED DUE ITS DOVETAIL LOCKING MECHANISM THAT SEEMED TO BE DAMAGED.

  Patient problems: Injury

  MAUDE report 9478608 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071071, 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
• Z-1507-2020 · Dec 19, 2019 · Terminated
  LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
• Z-1906-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and poste
• Z-1905-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and post
• Z-1907-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and poster
• Z-1904-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and post