LEGION 71421206Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556029138), received between Sep 6, 2018 and Sep 8, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED 6 MONTHS AGO, THE PATIENT WAS FOUND ITCHY AND WITH RASHES ON THE WOUND. SURGEON SUSPECTS THAT THE PATIENT IS ALLERGIC TO OXINIUM. NO REVISION IS NEEDED AT THIS MOMENT; PATIENT IS BEING TREATED WITH ANTI-BIOTICS.

  Patient problems: Itching Sensation; Rash

  MAUDE report 22993392 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON A CURRENTLY UNKNOWN DATE, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY AN ADDITIONAL SURGICAL INTERVENTION ON (B)(6) 2025, IN WHICH ONE (1) EVOS LARGE DISTAL FEMUR PERI PROSTHETIC PLATE WITH MULTIPLE CABLES WERE IMPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Periprosthetic fracture

  MAUDE report 22290399 ↗
• InjuryDec 10, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE OXINIUM FEMORAL COMPONENT WAS DAMAGED WHEN THE INLAY WAS IMPACTED. TWO BURRS OF APPROX. 1MM SIZE ABOVE THE NOTCH, NOT IN THE MAIN STRESS ZONE ARE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO OTHER COMPLICATIONS WERE 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 10987465 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED DUE TO THE PROGRESSION OF PATELLO FEMORAL OSTEOARTHRITIS AS A TREATMENT.

  Patient problems: Injury

  MAUDE report 9880338 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION OF A JOURNEY UNI KNEE WAS PERFORMED AND SUCCESSFULLY REVISED IT TO A PRIMARY LEGION P/S KNEE.

  Patient problems: Injury

  MAUDE report 8305988 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION OF A JOURNEY UNI KNEE WAS PERFORMED AND SUCCESSFULLY REVISED IT TO A PRIMARY LEGION P/S KNEE.

  Patient problems: Injury

  MAUDE report 8305926 ↗
• InjuryOct 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ASPIRATION OF FLUID WAS REQUIRED DUE TO "SWEELING".

  Patient problems: Injury; Joint Swelling

  MAUDE report 7985577 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO LIMITED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 7958152 ↗
• InjurySep 30, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT PRESENTED ASEPTIC LOOSENING AND PAIN ON HIS RIGHT KNEE SEVERAL YEARS AFTER TKR. KNEE PROSTHESIS WAS REMOVED ON REVISION SURGERY AND ANTIBIOTIC BEADS WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 7921373 ↗
• InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EFFUSION AND IT WAS TREATED WITH PUNCTURE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7852480 ↗

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-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 r
• 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.