LEGION 71453113Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556034538), received between Dec 14, 2017 and Feb 14, 2023 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2013 , THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH ONLY ONE (1) LGN CR HIGH FLEX XLPE SZ 3-4 13MM WAS EXCHANGED. HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16372554 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA HAD BEEN PERFORMED ON UNSPECIFIED DATE, THE PATIENT EXPERIENCED WOUND BREAKDOWN. THIS ADVERSE EVENT WAS TREATED ON (B)(6) 2021 WITH KNEE DEBRIDEMENT AND WASHOUT. ADDITIONALLY, THE LGN CR HIGH FLEX XLPE SZ 3-4 13MM WAS EXCHANGE TO LGN CR HIGH FLEX XLPE SZ 3-4 15MM, FOR PROPHYLACTIC PURPOSES. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Wound Dehiscence

  MAUDE report 12236076 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY HAD BEEN PERFORM ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON AN UNKNOWN DATE, IN WHICH ONE (1) LGN CR HIGH FLEX XLPE SZ 3-4 13 MM WAS REMOVED, AND REPLACED WITH ANOTHER CR HIGH FLEX SIZE 3-4 INSERT 13 MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12166008 ↗
• MalfunctionMay 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, IT WAS FOUND THAT THE SECOND INNER PACKAGE OF A LGN CR HIGH FLEX XLPE SZ 3-4 13MM WAS DAMAGED AFTER OPENING THE FIRST LAYER OF AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809070 ↗
• InjuryDec 21, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO REDUCED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8191909 ↗
• MalfunctionDec 18, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING SURGERY, THE DOCTOR OPENED THE PACKAGING AND FOUND THAT THE INNER PACKAGE HAD BEEN UNSEALED. THERE WAS NO ALTERED PRODUCT SO THE DEVICE WAS UTILIZED BY STERILIZED BY ISODINE. AS OF TODAY THERE IS NO HARM TO THE PATIENT LIKE THE INFECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8176345 ↗
• InjurySep 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 7921270 ↗
• InjuryDec 14, 2017Adverse 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 POSTERIOR CRUCIATE LIGAMENT INJURY. THE SURGEON CONSIDERED IT IS NOT THE PRODUCT FAILURE.

  Patient problems: Injury

  MAUDE report 7118521 ↗

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-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-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