LEGION 71453185Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556487440), received between Jan 10, 2019 and Aug 12, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED IN (B)(6) 2021, THE PATIENT EXPERIENCED KNEE INSTABILITY. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, AND IT WAS CONFIRMED THAT THE KNEE WAS UNSTABLE. THIS ADVERSE EVENT WAS SOLVED BY CHANGING THE INSERT (LGN CR HIGH FLEX XLPE SZ 5-6 10MM) BY A 5MM DEEP DISHED INSERT. THE PATELLA WAS ALSO RESURFACED AND A 32MM PATELLA INSERT WAS USED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12316526 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RECON SURGERY HAD BEEN PERFORMED, THE PATIENT REPORTED AN INFECTION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE LGN CR HIGH FLEX XLPE SZ 5-6 10MM, GII LNG STEM 10MM X 100MM, GNS II CMT TIB SIZE 6 LEFT, LEGION CR NP FEM SZ 6 LT, AND GNS II RESURF PAT 35MM. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 11843530 ↗
• InjuryJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY DUE TO DRAINAGE AFTER TOTAL KNEE REPLACEMENT. THE PATIENT WAS WASHED OUT AND TREATED WITH RE-ABSORBABLE ANTIBIOTIC BEADS AND AN INSERT EXCHANGE WAS PERFORMED.

  Patient problems: Joint Dislocation

  MAUDE report 8236238 ↗

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-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
• 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