LEGION 71453147Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556255346), received between Sep 5, 2018 and Nov 5, 2024 — classified as 2 injuries.

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

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

• InjuryNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A RIGHT TKR PERFORMED ON (B)(6) 2016, IN 2021 THE PATIENT STARTED HAVING PAIN BEHIND KNEE. BY (B)(6) 2022 IT WAS VERY DIFFICULT TO WALK. THE PATIENT SUFFERED WITH SO MUCH PAIN BEHIND KNEE AND SOMETIMES DOWN CALF. ON (B)(6) 2023 VISITED THE SURGEON AND X-RAY LOOKED FINE AND PHYSICAL THERAPY WAS RECOMMENDED. THE PATIENT INDICATES THAT THIS MADE IT WORSE. ON (B)(6) 2024 THE PATIENT VISITED THE ORTHOPEDIST AND X-RAY LOOKS OFF. A REVISION SURGERY WAS PERFORMED AND IT WAS FOUND THAT THE SPACER PIECE BROKE INTO PIECES. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Impingement; Joint Laxity; Pain

  MAUDE report 20610153 ↗
• InjurySep 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. THE BASEPLATE, THE INSERT AND THE FEMORAL COMPONENT WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 7846915 ↗

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-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
• 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