LEGION 71453204Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556034989), received between Jun 20, 2017 and Dec 20, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryDec 20, 2024Fracture; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Fracture; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA PERFORMED ON (B)(6) 2024. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO TWO INSERT DISSOCIATIONS AND PAIN. THE LGN PS HIGH FLEX XLPE SZ 1-2 15MM, THE GII CM TIB SIZE 2 {} RIGHT, AND THE LEGION PS OXIN FEM SZ4 RT WERE EXCHANGED FOR A LEGION INSERT, LEGION OX FEMORAL COMPONENT, AND LEGION BASEPLATE, RESPECTIVELY. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 20988457 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED PAIN, SWELLING, FEVER AND INFECTION. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023 TO TREAT THIS ADVERSE EVENT IN WHICH A LGN PS HIGH FLEX XLPE SZ 1-2 15MM WAS EXCHANGED WHILE A LGEN II 7.5MM RESUR PAT 26MM, LGN REV TIBIA BASE SZ 1 LT AND A LGN OX CONSTRAINED FEM 3 LT REMAINED. IN ADDITION, THE SURGEON DOES NOT BELIEVE THAT THE PRODUCT IS AT FAULT. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Arthralgia; Fever; Medical device site infection; Swelling/ Edema

  MAUDE report 18100847 ↗
• InjuryOct 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISENGAGE OF THE POLY.

  Patient problems: Injury

  MAUDE report 9177670 ↗
• InjurySep 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO A DISLODGED INSERT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6843013 ↗
• InjuryJun 20, 2017Loose or Intermittent Connection; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY WITH EXCHANGE OF POLY INSERT DUE TO INSERT DISLOCATION. POLY CAME OUT OF THE TRAY IN (B)(6) 2017, SURGEON REMOVED LOOSE POLY, INSPECTED THE LOCKING DETAIL ON THE TRAY AND PERFORMED A POLY SWAP.

  Patient problems: Joint Dislocation

  MAUDE report 6653274 ↗

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-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
• 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