LEGION 71421224Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556030066), received between Dec 21, 2018 and Aug 31, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K043440, K093746, 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.

• InjuryAug 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2022, A REVISION SURGERY WAS REQUIRED ON (B)(6) 2024 DUE TO FIXED FLEXION DEFORMITY. A LEGION CR OXIN FEM SZ4 RT AND A LGN CR HIGH FLEX XLPE SZ 3-4 9MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 20114245 ↗
• MalfunctionJan 20, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING SURGERY BLACK PARTICLES STUCK TO THE CEMENT WHILE CEMENTING LEGION OXINIUM FEMORAL COMPONENT. NO BACK UP WAS AVAILABLE. NO DELAY TO PROCEDURE OR INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9609256 ↗
• InjuryOct 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION AND A FEELING OF WRONGNESS. THREE PARTS WERE REMOVED: LEGION OX FEMORAL COMPONENT, LEGION BASE PLATE, LEGION INSERT. THESE COMPONENTS WERE REPLACED WITH: LEGION OX FEMORAL COMPONENT AND LEGION INSERT. PRE-EXISTING CONDITIONS: OSTEOARTHRITIS.

  Patient problems: Injury

  MAUDE report 9187441 ↗
• InjuryAug 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, IT IS UNKNOWN THE REASON FOR THIS REVISION.

  Patient problems: Injury

  MAUDE report 8862837 ↗
• InjuryDec 21, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO REDUCED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8191826 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043440, K093746, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0277-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POL
• Z-0278-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POL
• 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-1951-2021 · May 19, 2021 · Terminated
  LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Kn
• Z-2538-2019 · Jan 15, 2018 · Completed
  LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and
• Z-0816-2016 · Jan 18, 2016 · Terminated
  LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
• Z-1820-2009 · Jan 22, 2009 · Terminated
  LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
• Z-1819-2009 · Jan 22, 2009 · Terminated
  LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.