LEGION 71453257Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556255803), received between May 14, 2019 and Jun 4, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryJun 4, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA SURGERY, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGE A LGN XLPE PS INSERT SZ 7-8 9MM DUE TO THE IMPLANT POST BROKE. THE PATIENT COMPLAINED OF PAIN, AND POST WAS DISCOVERED UPON OPENING OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. A S+N IMPLANT WAS USED FOR REPLACEMENT. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11942701 ↗
• MalfunctionMay 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING A TKA, A LGN XLPE PS INSERT SZ 7-8 9MM WAS UNABLE TO BE SEATED IN PATIENT. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH AN AVAILABLE SMITH AND NEPHEW BACK UP DEVICE; THEREFORE, PATIENT WAS NOT HARMED.ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11902152 ↗
• InjuryMar 19, 2020Break; Break

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED NINE YEARS AFTER PRIMARY SURGERY DUE TO THE POST FROM THE LEGION XLPE PS INSERT SIZE 7-8 9MM BROKE. THE REASON FOR THE BREAKAGE IS NOT KNOWN.

  Patient problems: Injury

  MAUDE report 9857494 ↗
• InjuryMay 14, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT FRACTURE. PATIENT FAINTED AND FELL, BREAKING THE POST.

  Patient problems: Injury

  MAUDE report 8610485 ↗

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-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
• 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-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-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