LEGION 71453131Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556033555), received between May 8, 2017 and Nov 3, 2025 — classified as 7 injuries, 1 malfunction.

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

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED SOFT TISSUE LAXITY, WITHOUT SIGNS OF INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKR SURGERY ON (B)(6) 2025, IN WHICH THE LGN CR HIGH FLEX XLPE SZ 7-8 9MM WAS EXPLANTED AND IMPROVED BY UPSIZING THE POLY, AND PUTTING IN A DISHED VERSION. ALL OTHER COMPONENTS WERE WELL FIXED AND IN PERFECT CONDITION ON INSPECTION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 23460394 ↗
• InjuryOct 31, 2024Adverse 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 ON (B)(6) 2024 DUE TO OSTEOARTHRITIS, PATIENT EXPERIENCED KNEE STIFFNESS. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING MANIPULATION UNDER ANESTHESIA ON (B)(6) 2024, IN WHICH, IT WAS RESOLVED. ALTHOUGH, PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 20577779 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PREVIOUS REVISION SURGERY PERFORMED ABOUT 6 MONTHS AGO, THE SURGEON WANTED TO REPAIR THE MEDIAL RETINACULUM OF PATELLA. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2021, AND THE SURGEON DECIDED TO EXCHANGE THE LGN CR HIGH FLEX XLPE SZ 7-8 9MM TO PROVIDE BETTER STABILITY. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12639841 ↗
• MalfunctionJun 2, 2021Fitting Problem; Material Deformation; Fitting Problem; Material Deformation

  .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921486 ↗
• InjuryMay 14, 2021Pitted; Pitted

  IT WAS REPORTED THAT, AFTER A TKA, THE PATIENT PRESENTED WITH PAINFUL FROM INITIAL SURGERY ON (B)(6) 2018. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, AND WAS NOTED THAT THE LGN CR HIGH FLEX XLPE SZ 7-8 9MM INSERT WAS PITTED AND THE TIBIAL BASEPLATE WAS LOOSE. THE FEMORAL COMPONENT WAS ALSO EXTRACTED SECONDARY TO LOOSENING. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11826841 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS DONE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9281451 ↗
• InjuryMay 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION RIGHT TKA WAS PERFORMED DUE TO INFECTION AND ABSCESS. I&D RIGHT LEG ABSCESS AND I&D RIGHT KNEE JOINT PLUS LINER EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 6552901 ↗
• InjuryMay 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION OF THE RIGHT KNEE. ALL COMPONENTS WERE REMOVED AND CEMENT AND AN ANTI-BIOTIC SPACER WERE PLACED. THE PATIENT RETURNED ON (B)(6) 2016 TO REMOVE THE SPACER AND IMPLANT A COMPETITOR'S PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 6552685 ↗

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-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-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