LEGION 71453146Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556255353), received between Oct 18, 2018 and Feb 17, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryFeb 17, 2023Adverse 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) 2016 WITH OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2018 DUE TO THE FOLLOWING DIAGNOSIS/COMPLICATION(S): INSTABILITY, MALALIGNMENT AND IMPLANT FRACTURE. DURING THIS PROCEDURE, THE FEMORAL COMPONENT AND ARTICULAR INSERT WERE EXPLANTED AND REPLACED WITH A KNEE REVISION SYSTEM, AND THE PATELLA WAS RESURFACED. PER THE REGISTRY REPORT CONTENTS, IT IS NOT SPECIFIED WHICH OF THE EXPLANTED KNEE PROSTHESIS COMPONENTS FRACTURED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY TKR SURGERY WITH A KNEE PROSTHESIS CONSTRUCT THAT INCLUDED A GENESIS II OXINIUM FEMORAL COMPONENTS AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16396090 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DUE TO AN OVERSTUFFED JOINT AND A LOT OF SCAR TISSUE. A REVISION SURGERY WAS PERFORMED , REVISED POLY AND THE PATELLA TAKING OUT A BICONVEX AND IMPLANTING A 38MM OVAL PATELLA. THERE WAS NO IMPLANT FAILURE.

  Patient problems: Injury; Pain

  MAUDE report 9588415 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED WITH ERYTHEMA SWELLING SUPRAPATELLAR AREA FOR 2 WEEKS. SHE WAS COMPLAINED OF PAIN DUE TO CELLULITIS. THE PATIENT HAD PAIN STIFFNESS AND FAILED POST ATTEMPTS AND MANIPULATION OF THE RIGHT KNEE. SHE WAS ADMITTED FOR IV VANCOMYCIN ADMINISTRATION FOR SUSPECTED DEEP JOINT PROSTHETIC INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8205229 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT KNEE CLOSED MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT DUE TO ARTHROFIBROSIS, STATUS POST TOTAL KNEE ARTHROPLASTY.

  Patient problems: Fibrosis; Injury

  MAUDE report 8205228 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT (B)(6). WAS DIAGNOSED WITH FAILED RIGHT TOTAL KNEE ARTHROPLASTY WITH INSTABILITY, THIS HAPPENED FOUR YEARS AFTER HER REPLACEMENT ON 2014. PATIENT WAS TAKEN TO SURGERY AND THE POLYETHYLENE WAS REMOVED. A BIGGER POLY SIZE WAS IMPLANTED TO SOLVED THE INSTABILITY.

  Patient problems: Injury

  MAUDE report 7980223 ↗

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-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