LEGION 71421175Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010543912), received between Aug 26, 2019 and May 3, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A REVISION OF PARTIAL RIGHT KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A TRAUMATIC SUBCUTANEOUS RUPTURE OF THE RIGHT PATELLAR TENDON. THIS WAS TREATED BY PATELLAR TENDON REPAIR ON (B)(6) 2026, IN WHICH SURGICAL REPAIR OF THE TENDON WAS PERFORMED. SUBSEQUENTLY, THE PATIENT DEVELOPED LOCALIZED PAIN OF THE SURGICAL WOUND, FORMATION OF SCAR TISSUE, AND A SMALL SUPERFICIAL DEHISCENCE REQUIRING SURGICAL REVISION. DUE TO PROGRESSIVE LOCAL SEPTIC INFLAMMATION WITH INITIAL SYSTEMIC INVOLVEMENT, THE PATIENT WAS READMITTED ON (B)(6) 2026 FOR A PROSTHETIC INFECTION. THIS ADVERSE EVENT WAS TREATED BY COMPLETE PROSTHETIC EXPLANATION, SURGICAL CLEANING, AND REPLACEMENT WITH AN ANTIBIOTIC-IMPREGNATED CEMENT SPACER ON (B)(6) 2026. THE EXPLANTED PROSTHETIC COMPONENTS SHOWED NO SIGNS OF DAMAGE, BREAKAGE, WEAR, OR OTHER MECHANICAL PROBLEMS. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection; Muscle/Tendon Damage; Wound Dehiscence

  MAUDE report 25064270 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2008 DUE TO INFECTION. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. ON (B)(6) 2015 PATIENT STARTED TO PRESENT A LATE INFECTION WITH RECURRENCE TILL (B)(6) 2016. DURING THIS TIMEFRAME NO ACTIONS WERE TAKEN, OR ADDITIONAL INFORMATION WAS GIVEN ON HOW IT WAS TREATED. TILL 2020, 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: Medical device site infection

  MAUDE report 20337629 ↗
• InjurySep 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2006 DUE TO ASEPTIC LOOSENING AND INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 3,55 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 20317654 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2007 DUE TO OSTEOLYSIS, ASEPTIC LOOSENING AND INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. LATER ON THE SAME MONTH AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INFECTION 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: Post Operative Wound Infection

  MAUDE report 20311903 ↗
• InjuryOct 19, 2020Break; Break

  IT WAS REPORTED THAT DURING A PRIMARY KNEE WITH REVISION COMPONENTS. WHEN THE SURGEON, WAS REMOVING RETAINED CEMENT FROM THE BONE COMPONENT INTERFACE OF THE IMPLANT THAT WE HAD JUST CEMENTED IN A PIECE OF MATERIAL CAME OFF OF THE FEMORAL COMPONENT SURGEON WAS USING AN OSTEOTOME TO CHIP OFF CEMENT AND HE ACCIDENTALLY HIT THE MEDIAL SIDE OF THE COMPONENT WITH THE OSTEOTOME, WHICH CAUSED A PIECE OF THE OXINIUM MATERIAL TO COME OFF SURGEON DIDN¿T THINK THAT THIS SHOULD HAPPEN. IT WAS ON THE MEDIAL EDGE AND NOT IN AN AREA THAT ARTICULATES WITH THE POLY. UNFORTUNATELY THE PIECE THAT CAME OFF COULD NOT BE FOUND ON THE FLOOR. THE PIECE WAS NOT IN THE WOUND. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10701643 ↗
• InjuryOct 12, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LGN OX CONSTRAINED FEM 5 RT WOULD NOT TIGHTEN DOWN COMPLETELY EVEN WITH THE SCREW ALL THE WAY TIGHTENED. THIS RESULTED IN THE AUGMENT HAVING TO BE CEMENTED. THE PATIENT CONDITION IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10667456 ↗
• InjuryAug 26, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO INSTABILITY. A ZIMMER PRODUCT WAS IMPLANTED INSTEAD. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: Injury

  MAUDE report 8929125 ↗

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.