LEGION 71421204Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556030332), received between Oct 9, 2023 and Aug 20, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Degraded; Biocompatibility; Degraded; Biocompatibility

  IT WAS REPORTED THAT, AFTER TKA SURGERY/TREATMENT HAD BEEN PERFORMED ON (B)(6) 2018, IT WAS FOUND THAT THERE WAS A METAL FRAGMENT ON THE INSERT, AND WEAR OF THE FEMORAL COMPONENT OCCURRED DUE TO FRICTION WITH THE METAL FRAGMENT, WHICH CAUSED METALLOSIS. THIS ADVERSE EVENT WILL BE SOLVED BY A REVISION SURGERY ON (B)(6) 2025. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 22850524 ↗
• InjuryJun 21, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, A PATIENT HAS BEEN EXPERIENCING ADVERSE REACTIONS WITH THE OXINIUM IMPLANTS, REPORTING ECZEMA AND ALLERGY-LIKE SYMPTOM. THE PATIENT CLAIMS TO HAVE PAIN AND DISCOMFORT. ALL INVESTIGATIONS-MR, INFECTION MARKERS, CT SCANS FOR MALROTATION ARE CLEAR. THE IGE IS RAISED AS MARKER FOR ALLERGIES. NEVERTHELESS, THE PATIENT CONTINUES TO EXPERIENCE INFLAMMATION AND SEVERE DISCOMFORT EVEN AFTER TREATMENT WITH NSAIDS, ANTI-INFLAMMATORIES, AND A SHORT COURSE OF STEROIDS. HEALTHWISE, PATIENT'S CURRENT HEALTH STATUS IS OK. SURGEON IS POTENTIALLY CONSIDERING REVISION OF THE OXINIUM IMPLANTS.

  Patient problems: Discomfort; Eczema; Hypersensitivity/Allergic reaction; Implant Pain

  MAUDE report 19590039 ↗
• InjuryMay 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED KNEE PAIN AND SUSPECTED IMPLANT LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE LEGION PS OXIN FEM SZ4 RT, THE GNS II CMT TIB SIZE 3 RIGHT, AND THE LGN XLPE PS INSERT SZ 3-4 9MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 19313063 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON AN UNKNOWN DATE. PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Arthralgia

  MAUDE report 17895515 ↗

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.