LEGION 71421166Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010543851), received between Jan 27, 2021 and Mar 20, 2026 — classified as 3 injuries, 1 malfunction.

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

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

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED PATELLA DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED BY A SECOND REVISION SURGERY ON (B)(6) 2026, IN WHICH THE IMPLANTS WERE EXPLANTED AND REPLACED WITH FULL LEGION REVISION CONSTRUCT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24649358 ↗
• InjurySep 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN 2006 DUE TO STIFFNESS. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. LESS THAN A YEAR LATER 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 20313133 ↗
• MalfunctionFeb 8, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE THE POSTERIOR WEDGES ON THE LGN OX CONSTRAINED FEM 6 LT WILL NOT CORRECTLY SCREW INTO FEMUR. THERE WAS A DELAY OF LESS THAN 30 MIN. PROCEDURE CONCLUDED WITH THE SAME DEVICE. NO INJURIES REPORTED AT THIS TIME. 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 11291228 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED DUE TO PAIN, SWELLING, AND INFECTION. LEGION OXINIUM CONSTRAINED FEM 6 LEFTWAS EXPLANTED. HOWEVER, THE DOCTOR SAID THAT THE DEVICES WERE NOT DEFECTIVE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO COMPLICATIONS WERE REPORTED. NO PATIENT INFORMATION NEITHER MEDICAL REPORTS ARE AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 11235708 ↗

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-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.