LEGION 71453214Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556035108), received between Sep 21, 2017 and May 31, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED STIFFNESS IN JOINT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A LGN PS HIGH FLEX XLPE SZ 3-4 15MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 25341841 ↗
• InjuryOct 9, 2025Adverse 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, THE PATIENT EXPERIENCED A POLY LAXITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 3-4 15MM AND PATELLA (UNKN01200230) WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23263116 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL RIGHT KNEE REPLACEMENT SURGERY, THE IMPLANTED DEVICE REPORTEDLY FAILED. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21992300 ↗
• InjuryAug 13, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, IT WAS DISCOVERED THAT THE INSERT WAS NOT LOCKED INTO THE TIBIAL TRAY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. AFTER REMOVAL OF THE INSERT IT LOOKS LIKE THERE IS DAMAGE TO THE INSERT ON THE BOTTOM MEDIAL SIDE. DOCTOR EXAMINED TIBIAL BASEPLATE FOR DAMAGE DURING REVISION SURGERY AND DID NOT NOTICE ANY DAMAGE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17538091 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCE AN UNKNOWN ADVERSE EVENT WITH THE POLY BEING IMPLANTED. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 3-4 15MM. CURRENT HEALTH STATUS OF PATIENT IS ALSO UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13927070 ↗
• InjuryDec 29, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. DURING SURGERY, WAS FOUND THAT THE POST BROKE WHILE INSIDE THE PATIENT. THE LGN PS HIGH FLEX XLPE SZ 3-4 15MM WAS SWAPPED OUT. THE PATIENT OUTCOME IS NORMAL. NO FOREIGN BODY WAS RETAINED IN PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 11086717 ↗
• InjuryNov 5, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, AFTER A S&N LEGION REVISION SYSTEM HAD BEEN IMPLANTED IN A REVISION SURGERY, THE PATIENT EXPERIENCED INSTABILITY. IT IS UNKNOWN IF THE PREVIOUS REVISION SURGERY WAS FOR A S&N SYSTEM. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ADVERSE EVENT: AN EXCHANGE FROM A 15MM PS TO 18MM CONSTRAINED INSERT WAS DONE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10797061 ↗
• MalfunctionOct 2, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AFTER CEMENTING, THE LEGION PS HIFLEX INSERT SZ 3/4 15MM, WOULD NOT LOCK INTO THE BASEPLATE CORRECTLY. DR ATTEMPTED 3 TIMES AND IT WOULDN'T LOCK DOWN AT THE FRONT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO HARM TO PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10618892 ↗
• InjuryOct 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. AFTER APPROX. 6 WEEKS INSITU. INSERT DISLOCATED FROM LOCKING MECHANISM POST FALL. SURGEON BELIEVES ON INSPECTION THAT IT MAY HAVE NEVER BEEN LOCKED IN AT THE TIME OF PRIMARY SURGERY. SIGNS OF FEMORAL IMPLANT CONDYLAR WEAR ASSOCIATED WITH ARTICULATION WITH THE TIBIAL BASE PLATE. KINDLY INVESTIGATE THE EXPLANTED POLY.

  Patient problems: Joint Dislocation

  MAUDE report 7924166 ↗
• InjurySep 19, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE POLY WAS BROKEN. DR. REPLACE THE POLY TO A THICKER SIZE.

  Patient problems: Injury

  MAUDE report 7891685 ↗
• InjuryApr 6, 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 UNSTABILITY. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE.

  Patient problems: No Code Available

  MAUDE report 7404939 ↗
• InjuryOct 17, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT FELL FOLLOWING A MANIPULATION AND FRACTURED HER TIBIAL TUBERCLE IN (B)(6) 2017. THIS WAS MANAGED NON OPERATIVELY IN A SPLINT FOR 3 MONTHS. THE FRACTURE DISPLACED. THE FRACTURE WAS PLACED WITH 2 SCREWS AND TENSION BAND WIRING. ONCE FRACTURE HEALED THE STIFFNESS CONTINUED. A REVISION SURGERY WAS PERFORMED TO DOWNSIZE THE POLY AND RELEASE OF SOFT TISSUE WAS PERFORMED.

  Patient problems: Bone Fracture(s)

  MAUDE report 6955445 ↗
• InjurySep 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION KNEE SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6883504 ↗

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-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