LEGION 71453173Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556486948), received between Mar 19, 2018 and Feb 17, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT SHOWED SIGNS OF INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 3-4 10MM WAS REPLACED WITH A CONSTRAINED INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24366598 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY THE PATIENT PRESENTED WITH A PAINFUL KNEE IT WAS DETERMINED THERE WAS AN INFECTION. THE KNEE WAS WASHED OUT AND THE POLY INSERT WAS SWAPPED OUT. THE LEGION KNEE WAS IMPLANTED ABOUT 1 YEAR AGO. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 21240728 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2019 , IT WAS IDENTIFIED THAT THE LGN PS HIGH FLEX XLPE SZ 3-4 10MM WAS DAMAGED AND THE COATING ON THE LEGION PS OXIN FEM SZ7 RT WAS COMPLETELY WORN OFF. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 15674322 ↗
• InjuryNov 12, 2021Unintended Compatibility; Unintended Compatibility

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THEY REALIZED THAT THE WRONG SIZE INSERT WAS INSERTED INTO TIBIA IN ERROR. A SIZE 6 TIBIA WAS IMPLANTED ALONG WITH A LGN PS HIGH FLEX XLPE SZ 3-4 10MM. THE INSERT SHOULD NOT FIT, BUT IT DID SNAP INTO THE TIBIA; AND SINCE THE INSERT SNAPPED IN TO THE TIBIA WITHOUT NOTICEABLE ISSUES, IT WAS IMPLANTED AND PATIENT CLOSED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO IMPLANT THE CORRECT INSERT SIZE (LGN PS HIGH FLEX XLPE SZ 5-6 10MM). IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE ANY SYMPTOMS. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807198 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN ACUTE INFECTION STEMMING FROM WOUND ISSUE. AS IT WAS GROSSLY CONTAMINATED, A REVISION SURGERY WAS PERFORMED TO CHANGE THE LGN PS HIGH FLEX XLPE SZ 3-4 10MM SO THE KNEE COULD HAVE A BETTER CLEAN OUT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11696295 ↗
• MalfunctionMar 14, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A UNKNOWN PROCEDURE WHEN IMPACTING THE LGN PS HIGH FLEX XLPE SZ 3-4 10MM THE POLY DID NOT ENGAGE. SURGEON WAS UNSURE IF DAMAGED WHILE TRYING MULTIPLE TIMES TO IMPACT THE INSERT OF IT WAS A PRODUCT ISSUE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. THERE WAS A DELAY LESS THAN OR EQUAL TO 30MINS USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478887 ↗
• MalfunctionSep 18, 2020Unstable; Unstable

  IT WAS REPORTED THAT DURING A PROCEDURE THE LEGION PS HIGH FLEX XLPE SIZE 3-4 10MM COULD NOT SEAT ONTO THE BASEPLATE. A BACKUP DEVICE OF THE SAME SIZE WAS AVAILABLE AND USED. NO PATIENT HARM OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10557259 ↗
• InjurySep 1, 2020Adverse 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, THE PATIENT DEVELOPED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE LEGION PS HIGH FLEX XLPE SIZE 3-4 10MM INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10478524 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PREVIOUS FULL REVISION SURGERY HAD BEEN PERFORMED, ANOTHER REVISION SURGERY WAS PERFORMED DUE TO ARTHROFIBROSIS. THE LEGION PS HIGH FLEX XLPE SZ 3-4 10MM WAS EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10221512 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED THAT THE TKR HAS FAIL. SHE HAS FALL SEVERAL TIMES AND IT WAS CONFIRMED BY SURGEON A SURGERY MUST BE PERFORMED. THE DOCTOR THINKS THE INSERT SHOULD BE REPLACED, AWAITING ON CONFIRMATION FROM ANOTHER SURGEON. REVISION SURGERY HAS NOT BEEN SCHEDULED YET.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7349617 ↗

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-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
• 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