LEGION 71453112Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556034323), received between Jun 28, 2018 and May 15, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE AT AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN. THIS RESULTED ON A REVISION SURGERY ON (B)(6) 26 IN WHICH THE LGN CR HIGH FLEX XLPE SZ 3-4 11MM WAS EXCHANGED. NO FURTHER DETAILS AT THIS TIME.

  Patient problems: Pain

  MAUDE report 25185269 ↗
• InjuryJul 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER UNDERGOING A TKA ON (B)(6) 2018, PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE LGN CR HIGH FLEX XLPE SZ 3-4 11MM WAS EXCHANGED AND UPSIZED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 19730686 ↗
• InjuryApr 8, 2024Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE SURGEON BOUGHT THE PATIENT BACK TO THEATRE TO ADJUST THE PATELLA TRACKING ON (B)(6) 2024. ONCE THE KNEE WAS OPENED HE FOUND THE LGN CR HIGH FLEX XLPE SZ 3-4 11MM WAS SUB-LUXATING POSTERIORLY. PATELLA WAS NOT REPLACED. HE CHANGED THE INSERT TO A THICKER ONE. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Subluxation

  MAUDE report 19061692 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOME UNKNOWN TIME AFTER A KNEE RECONSTRUCTION SURGERY, THE PATIENT PRESENTED PAIN IN THE KNEE AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO EXCHANGE THE POLY CR SIZE 11MM AND RESURFACE THE PATELLA. PATIENT STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17122220 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT COMPLAINED OF RANGE OF MOTION (ROM) AND INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN ORDER TO EXCHANGE THE LGN CR HIGH FLEX XLPE SZ 3-4 11MM DEVICE, TRIAL DONE WITH 3/4 13MM DISHED TRIAL, 13MM DISH INSERT IMPLANTED. NO FURTHER INFORMATION AVAILABLE AT THIS MOMENT.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 16547297 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY WITH A LGN CR HIGH FLEX XLPE SZ 3-4 11MM THE WOUND HEALED IN THE FIRST STAGE AFTER THE OPERATION. FIVE WEEKS LATER, THE PATIENT EXPERIENCED THAT THE SUSPECTED THREAD SEGMENT AT THE PROXIMAL END OF THE WOUND WAS ELIMINATED, AND THE WOUND WAS PUNCTURED WITH A SELF SEWING NEEDLE. THE WOUND GRADUALLY BECAME RED AND SWOLLEN. THE LOCAL CLINIC CHANGED THE DRESSING AND APPLIED AN ANTI-INFLAMMATORY PLASTER EXTERNALLY. THE SYMPTOMS DID NOT IMPROVE AND THE EXTENT AND EXTENT OF THE REDNESS GRADUALLY EXPANDED. THIS ADVERSE EVENT WAS SOLVED BY WOUND DRESSING CHANGE, BACTERIAL CULTURE, ANTI INFECTION TREATMENT WITH SENSITIVE ANTIBIOTICS. THE WOUND HEALED AFTER INTRAVENOUS ANTIBIOTIC ANTI-INFECTION TREATMENT. PATIENT CURRENT HEALTH STATUS IS FINE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 15592195 ↗
• MalfunctionJun 22, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING KNEE SURGERY, IT WAS FOUND THAT A LEGION CR HIGH FLEX XLPE SIZE 3-4 11MM PACKAGE WAS NOT SEALED. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED (DELAY UNKNOWN) WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042918 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO ONGOING PAIN AND DISCOMFORT IT WAS DECIDED TO DO A REVISION SURGERY. IMPLANTS WERE WELL FIXED AND THERE WAS NO SIGNS OF INFECTION. SOFT TISSUE AND BONY DEBRIDEMENT WERE COMPLETED. IT WAS DECIDED TO PERFORM A POLY EXCHANGE. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Discomfort; Pain

  MAUDE report 11478926 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR PAIN/ DUE TO A FAILED POLY AT APPROXIMATELY 10 YEARS AFTER THE INITIAL SURGERY. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11326551 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE LGN CR HIGH FLEX XLPE SZ 3 4 11MM WAS NOT DELIVERED AFTER IT WAS USED THE DAY BEFORE. WAS ONLY NOTICED AFTER THE DOCTOR DECIDED TO CHANGE THE INLAY FOR A SECONDARY PATELLA REPLACEMENT IN A LEGION KNEE IN 2014. THE DOCTOR THEREFORE HAD TO RE IMPLANT THE REMOVED INLAY. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO APPARENT DELAY INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10804468 ↗
• InjuryJun 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. DEBRIDEMENT AND INSERT EXCHANGE WERE CONDUCTED.

  Patient problems: Unspecified Infection

  MAUDE report 8663525 ↗
• InjuryDec 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ASPIRATION WAS PERFORMED FOR CELL COUNT DUE TO PAIN.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 8189972 ↗
• InjuryDec 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN ASPIRATION PERFORMED FOR SYNOVASURE STUDY DUE TO PAIN.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 8189875 ↗
• InjuryJun 28, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATELLA WAS LOOSE AND WAS REMOVED EASILY. THE INSERT WAS EXCHANGED.

  Patient problems: Failure of Implant

  MAUDE report 7644666 ↗

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-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-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