LEGION 71421164Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010543837), received between Oct 12, 2018 and Oct 14, 2024 — classified as 4 injuries, 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Oct 2, 2024Class IIOpen, Classified

   Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

   Z-0278-2025 · Root cause: Packaging change control · Recall details · FDA record ↗

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.

• MalfunctionOct 14, 2024Packaging Problem; Wrong Label; Packaging Problem; Wrong Label

  IT WAS REPORTED THAT, DURING TKA REVISION SURGERY DUE TO IMPLANT LOOSENING, BOX AND STICKERS INDICATED THAT ONE (1) LGN OX CONSTRAINED FEM 4 LT WAS CONTAINED WITHIN THE PACKAGE, BUT INSTEAD IT CONTAINED ONE LGN OX CONSTRAINED FEM 3 LT (PART NUMBER 71421163; LOT NUMBER 23LM00479). THE DEVICE DIFFERENCE WAS NOTICED OUTSIDE THE PATIENT WHEN THE L-WEDGE BEING INSTALLED DID NOT FIT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20445510 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEGAL CASE: IT WAS REPORTED THAT, AFTER A PROSTHETIC RE-IMPLANT HAD OCCURRED ON (B)(6) 2018 WITH A LEGION KNEE SYSTEM, THE PATIENT STARTED EXPERIENCING PAIN. THE X-RAYS SHOWED THE FEMORAL AND THE TIBIAL STEMS WITH PHLOGOSIS. A REVISION SURGERY WAS NECESSARY TO REMOVE THE WHOLE SYSTEM AND REPLACED IT WITH CEMENT SPACERS ON (B)(6) 2021. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Inflammation

  MAUDE report 11806625 ↗
• InjurySep 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL PARTS WERE REMOVED AND REPLACED WITH CEMENT MOULDS FROM HERAEUS. NO MORE INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9073106 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FAILED PREVIOUS TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury

  MAUDE report 8348753 ↗
• InjuryOct 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LEFT KNEE ARTHROSCOPY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7962370 ↗

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-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-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.