LEGION 71453249Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556255872), received between Nov 4, 2020 and Jul 7, 2022 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionJul 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, WHEN OPENING A LGN XLPE PS INSERT SZ 3-4 15MM, IT WAS FOUND THAT IT WAS ALREADY OPEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951337 ↗
• InjuryJan 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING PROCEDURE, LEGION XLPE PS INSERT SIZE 3-4 15MM DID NOT LOCK INTO TIBIA. PROCEDURE CONTINUED WITH A CONSTRAINED INSERT, WITHOUT A DELAY OR AND INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187810 ↗
• MalfunctionJan 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, LEGION XLPE PS INSERT SIZE 3-4 15MM WOULD NOT LOCK ONTO TIBIA. PROCEDURE CONTINUED WITH A BACKUP DEVICE, WITHOUT A DELAY OR AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187795 ↗
• MalfunctionNov 4, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING SURGERY, THE INSERT WOULD NOT PROPERLY LOCK IN PLACE WITH TIBIA AND INSERTER TOOL DID NOT FIT PROPERLY ONTO ANTERIOR SLOT OF THE INSERT. PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THIS FAILURE. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788320 ↗

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