LEGION 71421168Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010543875), received between Nov 2, 2018 and Dec 30, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K043440, 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 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON A CURRENTLY UNKNOWN DATE,THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE LGN OX CONSTRAINED FEM 8 LT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025 IN WHICH ONE (1) LGN OX CONSTRAINED FEM 8 LT, ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 15MM, AND ONE (1) LGN PRESSFIT STEM 20MM X 160MM WERE REVISED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 23926735 ↗
• InjuryOct 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN 2010 DUE TO ASEPTIC LOOSENING AND INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 2,10 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20418519 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A LEFT TKA REVISION DUE TO ASEPTIC LOOSENING AS PRIMARY DIAGNOSIS WITH BEARING WEAR, OSTEOLYSIS, INSTABILITY AND FAILED PATELLAR COMPONENT AS SECONDARY DIAGNOSES. APPROXIMATELY SIX (6) MONTHS AFTER THIS PROCEDURE, THE PATIENT EXPERIENCED INSTABILITY IN THE REVISED KNEE AND REQUIRED A SECOND REVISION. THE DATES IN WHICH THE INDEX SURGERY, FIRST REVISION AND SECOND REVISION TOOK PLACE ARE NOT KNOWN. IT IS ALSO UNKNOWN WHICH DEVICES WERE EXPLANTED AND/OR EXCHANGED DURING THE SECOND REVISION. THIS INCIDENT WAS IDENTIFIED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING TKA REVISION OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16210072 ↗
• MalfunctionMar 1, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE SCREW OF THE POSTERIOR WEDGE COULD NOT FULLY ENGAGE WITH THE LEGION OXINIUM FEMUR SCREW HOLE. BECAUSE OF THIS THE POSTERIOR WEDGE COULD NOT BE PROPERLY TIGHTENED AND WOULD STAY A BIT LOOSE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391137 ↗
• InjuryNov 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PAINFUL PATELLOFEMORAL CREPITATION ONE YEAR AFTER KNEE WAS REPLACED AND HAD INJECTED WITH 3CC XYLOCAINE, 3CC MARCAINE, 1CC DEPO-MEDROL.

  Patient problems: Pain

  MAUDE report 8035671 ↗

Recalls under the same FDA submission

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

• 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-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-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-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.
• 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.