LEGION 71453123Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556035344), received between Mar 13, 2018 and May 22, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE LGN CR HIGH FLEX XLPE SZ 5-6 13MM WAS OPENED, DR KRENZEL INSPECTED THE POLY AND NOTICED SOME PITTING AND IMPERFECTIONS IN THE ARTICULATING SURFACE ON THE POSTERIOR PORTION NEAR THE POSTERIOR LIP AND DID NOT WANT TO USE IT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975976 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC ARTHRITIS, AND IT WAS A POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 9255823 ↗
• MalfunctionAug 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO POLY DISENGAGE. ALSO IT WAS NOTED THAT THERE WAS MINIMAL SCRATCHING ON THE FEMUR, AND THE LOCKING MECHANISM ON THE TIBIA WAS DAMAGED, THEREFORE, SURGEON DECIDED TO MOVE AHEAD WITH FULL REVISION SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920518 ↗
• InjuryMar 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT FELL AND THEN COMPLAINED OF PAIN IN THEIR KNEE. UPON SEEING THE PATIENT, DR. DETERMINED THAT THE PATIENT HAD DAMAGED THEIR PCL. THE PRIMARY KNEE IMPLANTS IN THE PATIENTS KNEE SEEMED TO BE LOOSE. A REVISION WAS DONE TO CORRECT THE PATIENTS KNEE PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7333310 ↗

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-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-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-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