LEGION 71424005Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010546098), received between Sep 24, 2019 and Apr 21, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA REVISION SURGERY PERFORMED ON (B)(6) 2025, IT WAS NOTICED THAT THE INSERT OBSERVED WAS DAMAGED AND LOOSE. A REPLACEMENT INSERT WAS CHOSEN, BUT IT WOULD NOT FIT, POSSIBLY DUE TO A DEFECTIVE LOCKING MECHANISM ON THE (1) LGN REV TIBIA BASE SZ 5 L. THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE, AFTER A SIGNIFICANT DELAY. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875689 ↗
• InjuryNov 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN 2017 DUE TO FEMORAL LOOSENING. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 2.15 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 20735838 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN (B)(6) 2017 DUE TO ASEPTIC LOOSENING. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0,1 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INFECTION THAT REQUIRED A 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: Medical device site infection

  MAUDE report 20625104 ↗
• InjuryAug 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED IMPLANT LOOSENING. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH AN UNKNOWN LEGION TOTAL KNEE REVISION FEMORAL COMPONENT, A LGN REV TIBIA BASE SZ 5 LT AND A GNS II CON INS SZ5-6 18MM WERE REPLACED WITH LEGION REVISION IMPLANTS. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15321212 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED PAIN. THE PHYSICIAN MENTIONED THAT THE LGN REV TIBIA BASE SZ 5 LT WAS SHOWING RED ON THE BONE SCAN REPORT AND THAT THE TKR REPLACEMENT WAS MOST LIKELY INFECTED; THEREFORE, AN ANTIBIOTIC SPACER WAS NEEDED. THIS ADVERSE EVENT WAS SOLVED BY A THIRD REVISION SURGERY ON (B)(6) 2022, IN WHICH THE LGN REV TIBIA BASE SZ 5 LT WAS EXPLANTED, AND GII IMPLANTS WERE IMPLANTED WITH ANTIBIOTICS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 13996201 ↗
• 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. LGN REV TIBIA BASE SZ 5 LT WAS 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 11236172 ↗
• InjuryJun 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD REPLACEMENT SURGERY ON (B)(6) OF 2020. THE UNIT OF LEGION RK REVISION KNEE MAKES EXCESSIVE NOISE (GRINDING/POPPING) WHEN WALKING. THE PATIENT ALSO HAS CONTINUOUS PAIN/STIFFNESS ON THE LEFT SIDE OF THE KNEE SINCE THE REPLACEMENT SURGERY. THE PATIENT HAS BEEN ATTENDING PHYSICAL THERAPY 3 TIMES PER WEEK AND TREATING THE PAIN WITH MEDICATION. THERE ARE NO MEDICAL INTERVENTIONS DONE DUE TO THIS ISSUE.

  Patient problems: Injury

  MAUDE report 10145537 ↗
• InjuryJan 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ANTIBIOTIC SPACERS WERE ALSO IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9641674 ↗
• InjurySep 24, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE TIBIA WAS REVISED FOR LOOSENING.

  Patient problems: Joint Dislocation

  MAUDE report 9109531 ↗

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 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.