LEGION 71453285Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556255636), received between May 4, 2018 and Feb 12, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2024Adverse 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) 2023, THE PATIENT START TO DEVELOPING ATHEROSCLEROSIS AND NOT BEING ABLE TO BEND HER KNEE PROPERLY. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE LGN XLPE DISHED ISRT SZ 5-6 11MM WAS EXCHANGE. THE REST OF IMPLANTS APPEARED IN PRISTINE CONDITION. PATIENT IS RECOVERING WELL, STILL IN HOSPITAL.

  Patient problems: Arteriosclerosis/ Atherosclerosis; Loss of Range of Motion

  MAUDE report 18684472 ↗
• InjuryOct 22, 2023Adverse 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 AN UNKNOWN DATE, THE PATIENT COMPLAINED OF LAXITY IN THE JOINT. THIS ADVERSE EVENT WILL BE TREATED BY A REVISION SURGERY ON AN UNKNOWN DATE, IN WHICH THE INSERT WILL BE EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17982414 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN A SZ 5-6 11MM LEGION DISHED INSERT, THE POLY WAS CHANGED DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 10786082 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION, ONLY POLY WAS EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8051052 ↗
• InjuryOct 25, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT'S X-RAYS SHOWED THAT COMPONENT WAS LOOSE. NO PROCEDURE, DELAY OR ADDITIONAL INJURIES REPORTED. BACK UP AVAILABLE.

  Patient problems: Injury

  MAUDE report 8005279 ↗
• InjuryMay 4, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

  Patient problems: Injury

  MAUDE report 7488998 ↗

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-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-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-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