LEGION 71453221Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00885556035337), received between Aug 7, 2017 and Sep 28, 2025 — classified as 53 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6)2010, THE PATIENT EXPERIENCED A FRACTURED POST. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6)2025. PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164097 ↗
• InjuryAug 19, 2025Adverse 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 (B)(6) 2011, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY PRIMARY PATELLA DONE ON PATIENT ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 22840570 ↗
• InjuryAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKE OFF IN THE POST OF THE POLY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS REVISED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 22709042 ↗
• InjuryJul 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY THAT HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT HAD A BROKEN POST ON PS INSERT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS REMOVED AND REPLACE WITH A NEW IMPLANT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 22465429 ↗
• InjuryJun 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON (B)(6) 2024, THE PATIENT PRESENTED INSTABILITY. THIS RESULTED ON A REVISION SURGERY TAKING PLACE ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS EXPLANTED AND REPLACED WITH AN 11MM POLY. CURRENT PATIENT STATUS IN UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22304618 ↗
• InjuryMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PS POST OF ONE (1) GN PS HIGH FLEX XLPE SZ 5-6 9MM BROKE. THIS ADVERSE EVENT WAS SOLVED BY ON (B)(6) 2025, IN WHICH THE INSERT WAS EXCHANGE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 22054203 ↗
• InjuryFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA, THE PATIENT PRESENTED INSTABILITY, AFTER THAT PATIENT'S LGN PS HIGH FLEX XLPE SZ 5-6 9MM POST BROKE OFF DUE TO PICKLEBALL OR OTHER ACTIVITY RELATED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025 IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS EXPLANTED AND CHANGED. UPON ENTERING THE JOINT, THE POST WAS SHEARED OFF AND LOCATED IN THE PS BOX REGION. THE CURRENT PATIENT'S STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 21458565 ↗
• InjuryFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A POST FRACTURE OF ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 9MM. THIS ADVERSE EVENT WAS RESOLVED THROUGH REVISION SURGERY BY IMPLANTING ONE (1) 5-6 9MM DISHED, DESPITE IT BEING OFF-LABEL AND NOT RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21313949 ↗
• InjuryJan 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SECOND SURGERY TO GET THE PATELLA RESURFACED. DURING THE PROCEDURE THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS BEING REMOVED AND IT WAS NOTICED THAT THE POST HAD BROKEN OFF. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 21264203 ↗
• InjuryJan 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A BILATERAL TKA SURGERY HAD BEEN PERFORMED ON 2009, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 DUE TO A BROKEN LGN PS HIGH FLEX XLPE SZ 5-6 9MM, IN WHICH IT WAS EXPLANTED AND REPLACED. IN ADDITION, THE PATELLA WAS RESURFACE USING A GNS II RESURF PAT 35MM. PATIENT IS A LARGE ACTIVE MALE, CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21085702 ↗
• InjuryAug 15, 2024Adverse 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, THE PATIENT EXPERIENCED CHRONICALLY DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6)2024, IN WHICH A LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS EXCHANGED WITH A CONSTRAINED POLY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19990948 ↗
• InjuryMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2014, THE POST OF A LGN PS HIGH FLEX XLPE SZ 5-6 9MM BROKE OFF. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE INSERT WAS EXCHANGED TO ONE OF THE SAME SIZE. THE SURGEON INDICATED THAT THE IMPLANT BREAKAGE WAS CAUSED BY THE PATIENT'S MOVEMENTS WHILE PLAYING BOWLING. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19313500 ↗
• InjuryMay 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON A UNKNOW DATE, THE PATIENT EXPERIENCED A BREAK OF THE POST OF THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS EVENT, IN WHICH THE INSERT WAS REPLACED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Failure of Implant

  MAUDE report 19240111 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT AFTER A RIGHT TKA HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT COMPLAINED OF HOT PAINFUL KNEE AND WAS UNABLE TO BEAR WEIGHT DUE TO THE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. THE JOINT WAS WASHED OUT AND REPLACED WITH A LGN PS HIGH FLEX XLPE SZ 5-6 9MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 18720075 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT COMPLAINED OF HOT PAINFUL KNEE AND WAS UNABLE TO BEAR WEIGHT DUE TO THE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. THE JOINT WAS WASHED OUT AND REPLACED WITH A LGN PS HIGH FLEX XLPE SZ 5-6 9MM . PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18707450 ↗
• InjuryJul 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED APPROXIMATELY TWELVE (12) YEARS AGO, THE POST OF A LGN PS HIGH FLEX XLPE SZ 5-6 9MM FRACTURED OFF. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. THE ISSUE HAS BEEN RELATED TO HIGH ACTIVITY LEVEL OF THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT LEFT SURGERY IN GOOD HEALTH. NO DELAY IN PROCEDURE REPORTED. NO FURTHER MEDICAL HISTORY.

  Patient problems: Failure of Implant

  MAUDE report 17274331 ↗
• InjuryJun 6, 2023Break; Break

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE, PERFORMED ON (B)(6) 2015, THE POST OF A LGN PS HIGH FLEX XLPE SZ 5-6 9MM BROKE, SO A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023. THE ADVERSE EVENT HAS BEEN RELATED TO HIGH ACTIVITY LEVEL AND THE WEIGHT OF THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 17071670 ↗
• InjuryMay 20, 2023Migration; Migration

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT COMPLAINED OF WEAKNESS WHEN STRAIGHTENING THE LEG, AND IT WAS NOTICED THAT THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM HAD SLIPPED FORWARD. SO A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, WHERE THE 5-6 9MM WAS REPLACED BY A 5/6-11 XLPE INSERT. WHEN THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS TAKEN OUT, A PIECE OF THE INSERT GROOVE WAS MISSING, BUT NO RESIDUE WAS FOUND IN THE PATIENT'S BODY.

  Patient problems: Discomfort; Joint Dislocation

  MAUDE report 16970550 ↗
• InjuryFeb 3, 2023Adverse 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) 2010, THE PATIENT EXPERIENCED KNEE PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE UNKN LEGION TIB INSERT WAS REPLACED WITH A LGN XLPE PS INSERT SZ 5-6 9MM. SURGEON THOUGHT THE POST HAD BROKEN ON THE INSERT, BUT, IT DID NOT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 16297678 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2021, THE PATIENT EXPERIENCED INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM AND CHANGED TO A CONSTRAINED INSERT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 16187907 ↗
• InjuryJan 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, A REVISION SURGERY WAS CONDUCTED. DURING THIS PROCEDURE, IT WAS OBSERVED THAT THE PS HF INSERT 5-6 9MM THAT WAS IMPLANTED IN THE PATIENT HAD THE POST BROKE OFF. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16092938 ↗
• InjuryDec 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, SIX (6) WEEKS AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT WAS PRESENTED TO THE ER WITH A DISLOCATED KNEE. ON THE (B)(6) 2022 A CLOSED REDUCTION WAS ATTEMPTED BUT WAS NOT SUCCESSFUL. A REVISION SURGERY WAS OPTED AND AMONGST THE FINDINGS, IT WAS NOTED THAT THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS NOT LOCKED INTO THE TIBIAL TRAY. THE POLY INSERT LOOKS TO HAVE VERY MINIMAL DAMAGE TO LOCKING MECHANISM. THE 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: Joint Dislocation

  MAUDE report 16015036 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED USING THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM DEVICE, THE PATIENT PRESENTED MEDIAL JOINT PAIN/LAXITY. DUE TO THIS, A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM DEVICE TO A CONSTRAINED INSERT. FURTHER DETAILS NOT AVAILABLE YET.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15985423 ↗
• MalfunctionOct 4, 2022Fracture; Device Damaged Prior to Use; Scratched Material; Fracture; Device Damaged Prior to Use; Scratched Material

  IT WAS REPORTED THAT DURING SET UP AND INSPECTION, A LGN PS HIGH FLEX XLPE SZ 5-6 9MM WAS FOUND WITH A VISIBLE MANUFACTURING ERROR. ON THE PICTURE PROVIDED IT APPEARS TO BE A FRACTURE ON ONE SIDE OF THE DEVICE. AS THIS WAS NOTICED DURING SET UP OR INSPECTION, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535501 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TKA SURGERY PERFORMED ABOUT 10-15 YEARS AGO, THE PATIENT WENT THROUGH A REVISION SURGERY ON (B)(6) 2022 PER STANDARD PRACTICE. FURTHER INFORMATION IS UNKNOWN AND IS NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15535476 ↗

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-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-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