LEGION 71453234Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556034507), received between Oct 16, 2018 and Mar 12, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2010, THE POST OF ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 15MM BROKE. AS A RESULT, THE PATIENT EXPERIENCED RIGHT KNEE INSTABILITY WITH A/P SUBLUXATION. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025. THE CURRENT HEALTH STATUS IS REPORTEDLY "USUAL STATE OF HEALTH".

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 21589108 ↗
• InjuryDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A FIRST REVISION OF THE LEFT TIBIAL COMPONENT IN (B)(6) 2014, A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO THE BREAKAGE OF THE LGN PS HIGH FLEX XLPE SZ 7-8 15MM POST. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20843257 ↗
• InjuryJul 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA PERFORMED AT AN UNKNOWN DATE, THE LGN PS HIGH FLEX XLPE SZ 7-8 15MM HAD TO BE EXPLANTED AND EXCHANGED DUE TO BREAKAGE ON A REVISION SURGERY PERFORMED ON (B)(6) 2023. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17295201 ↗
• MalfunctionMay 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON 2013, THE PATIENT EXPERIENCED BREAKAGE OF THE IMPLANTED LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS-LINKED POLYETHYLENE SIZE 7-8. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14290980 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED ACUTE INFECTION OF LEFT KNEE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. THE DR. CONDUCTED AN OPEN WASHOUT AND DEBRIDEMENT WITH INSERT AND PATELLA REVISION. TISSUE SAMPLES WERE SENT TO PATHOLOGY. THE WOUND IRRIGATED WITH BETADINE AND SALINE AND CLOSED AS PER STANDARD TECHNIQUE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12639754 ↗
• InjuryJan 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IN A TOTAL KNEE ARTHROPLASTY THERE WAS A POLY SWAP AND WASHED OUT PERFORMED. IT IS UNKNOWN IF THE EVENT HAPPENED BEFORE, DURING OR AFTER PROCEDURE. NO DELAY. SMITH AN NEPHEW BACK UP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11136379 ↗
• InjurySep 1, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE A FRACTURED INSERT. PATIENT PRESENTED A UNSTABLE KNEE.

  Patient problems: Injury

  MAUDE report 8953076 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PT. HAD TKA (B)(6) 2013 . JUMPED OFF OF FENCE SHEARED THE POST.

  Patient problems: Injury

  MAUDE report 7970314 ↗

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-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-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