LEGION 71424003Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010546074), received between Oct 12, 2018 and Aug 29, 2025 — classified as 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A REVISION OF UKA TO TKA USING CORI, AFTER THE CEMENT SET, THE TRIAL POLY WAS REMOVED AND TRIED TO INSERT THE DEFINITIVE. THE SURGEONS COULD NOT LOCK THE GII PS INSERT SZ 3-4 9MM INTO THE LGN REV TIBIA BASE SZ 3 LT. THEY STATED THAT THE SOFT TISSUE WAS NOT PREVENTING IT AS THE TIBIA WAS COMPLETELY SUBLUXATED WITH COMPLETE EXPOSURE AND NOTHING IMPEDING THE POLY AT ALL. AFTER MULTIPLE TRIES, COMPLETELY CLEANING THE BASEPLATE AND REINSERTING, IT WOULD STILL NOT LOCK, EVEN ON THE BACK TABLE REMOVING THE IN-SITU LGN REV TIBIA BASE SZ 3 LT AND LGN PRESSFIT STEM 14MM X 120MM, THEY TRIED TO TEST THE NEW BASEPLATE WITH POLY, AND IT WOULD NOT LOCK. FOR 60 MINUTES, THE SURGEONS TRIED WITH ALL COMBINATIONS BETWEEN ONE (1) LEGION CON ART INS 9MM SZ 3-4; TWO (2) GII PS INSERT SZ 3-4 9MM; ONE (1) LGN REV TIBIA BASE SZ 4 LT; ONE (1) LGN REV TIBIA BASE SZ 3 LT AND TWO (2) GII ARTICULAR INSERTER/EXTRACT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 22926710 ↗
• InjuryOct 25, 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 2014 DUE TO SUBSIDENCE OF TIBIAL BASE PLATE. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.41 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INFECTION THAT REQUIRED A TWO STAGE 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: Medical device site infection

  MAUDE report 20534190 ↗
• InjuryJul 26, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT DURING TKA, THE SURGEON SELECTED A LGN REV TIBIA BASE SZ 3 LT HOWEVER, INSIDE ITS EXTERNAL PACKING THERE WAS A PACKAGE WITH A LGN REV TIBIA BASE SZ 3 RT (71424013 LOT: 18HM04753). WHEN THE INTERNAL PACKAGE WAS OPENED IT WAS VERIFIED THAT THE IMPLANT HAD THE DESCRIPTION OF THE LGN REV TIBIA BASE SZ 3 RT ENGRAVED AND NOT THE LGN REV TIBIA BASE SZ 3 LT THAT WAS MEANT FOR USE. A SMITH AND NEPHEW LEFT TIBIAL BASE SIZE 4 WAS USED TO COMPLETE THE SURGERY WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104701 ↗
• 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 9073093 ↗
• InjuryJul 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SECOND STAGE REVISION WAS PERFORMED DUE TO INFECTION AND LOOSENING.

  Patient problems: Unspecified Infection

  MAUDE report 8814265 ↗
• 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 8348887 ↗
• InjuryDec 10, 2018Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO JOINT INSTABILITY.

  Patient problems: Injury

  MAUDE report 8147185 ↗
• 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 7961984 ↗

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 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.