LEGION 71453172Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556486894), received between Aug 20, 2018 and Feb 20, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A FEW MONTHS AFTER A TKR WAS PERFORMED IN (B)(6) 2018, THE PATIENT WAS EXPERIENCING JOINT TIGHTNESS AND REQUIRED A MUA. APPROXIMATELY 5 YEARS AFTER THIS EVENT, THE PATIENT REQUIRED AN INLAY EXCHANGE DUE TO JOINT INSTABILITY.

  Patient problems: Loss of Range of Motion

  MAUDE report 16406342 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A FEW MONTHS AFTER A TKR WAS PERFORMED IN (B)(6) 2018, THE PATIENT EXPERIENCED JOINT INSTABILITY AND ON (B)(6) 2023 A REVISION SURGERY WAS PERFORMED. DURING THIS PROCEDURE, THE SURGEON EXCHANGED ONE (1) LGN PS HIGH FLEX XLPE SZ 1-2 12MM WITH A 15MM CONSTRAINED INSERT TO IMPROVE THE STABILITY OF THE JOINT. PATIENT IS CURRENTLY RECOVERED AND WELL.

  Patient problems: Joint Laxity

  MAUDE report 16382002 ↗
• MalfunctionMay 4, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY WHEN THE INSTRUMENT WAS OUTSIDE THE PATIENT. THE PHYSICIAN WAS AT THE TIBIAL INSERTION STAGE OF A LGN PS HIGH FLEX XLPE SZ 1-2 12MM. THE TIBIAL INSERT WAS INSERTED INTO THE BASEPLATE AND IMPACTED WITH THE INSERTER TOOL. THE INSERT DID NOT LOCK DOWN FLUSH WITH THE BASEPLATE. THEN, IT WAS REMOVED AND THE LOCK MECHANISM ON BOTH PARTS WAS THOROUGHLY CLEANED. THIS WAS REPEATED 3 TIMES AND THEN A REPLACEMENT INSERT WAS OPENED WHICH LOCKED IN ON THE FIRST ATTEMPT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773706 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED BECAUSE THE PATIENT PRESENTED AN INFECTION AND FEVER. THE SURGEON SAYS THE DEVICES WERE NOT DEFECTIVE. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10681881 ↗
• InjuryAug 20, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SUSPICION OF INFECTION. DURING REVISION SURGERY, IT WAS DISCOVERED THAT THE PROBLEM WAS A DISASSOCIATION.

  Patient problems: Injury

  MAUDE report 7799383 ↗

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