LEGION 71453291Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556255582), received between Jun 7, 2018 and Jul 28, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER AN INITIAL LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2012 DUE TO SEVERE POST-TRAUMATIC ARTHRITIS, THE PATIENT EXPERIENCED POLYETHYLENE WEAR OF THE ARTICULAR INSERT, SYNOVITIS AND OSTEOLYTIC EROSION UNDER THE MEDIAL TIBIAL PLATEAU. PLAINTIFF UNDERWENT A LEFT REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, ONLY THE PATELLA COMPONENT WAS RETAINED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15122988 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PATIENT SHOWING SIGNS OF ASEPTIC LOOSENING OF HIS TIBIAL COMPONENT POST TKR. TIBIAL AND PATELLA COMPONENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396471 ↗
• InjuryNov 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT WHEN TRYING TO IMPLANT, BOTH OF THE FINAL POLYS WOULD NOT COMPLETELY SEAT INTO THE TIBIAL TRAY, EVEN THOUGH BOTH LOCKING MECHANISMS APPEARED TO BE IN GOOD CONDITION. A DELAY GREATER THAN 30 MINUTES WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8107855 ↗
• InjuryNov 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT WHEN TRYING TO IMPLANT, BOTH OF THE FINAL POLYS WOULD NOT COMPLETELY SEAT INTO THE TIBIAL TRAY, EVENT HOUGH BOTH LOCKING MECHANISMS APPEARED TO BE IN GOOD CONDITION. A DELAY GREATER THAN 30 MINUTES WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8107826 ↗
• InjuryJun 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT HAD A LEGION/GENESIS KNEE IMPLANT ON (B)(6) 2015 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO INSTABILITY AND LEFT KNEE GIVING AWAY, PAIN, SWELLING, ACCOMPANIED BY WARMTH, ERYTHEMA AND FEVERS.

  Patient problems: Injury

  MAUDE report 7576906 ↗

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-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
• 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