LEGION 71421207Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556029404), received between Aug 23, 2018 and Jul 11, 2023 — classified as 8 injuries.

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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2023Loss of Osseointegration; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS CONDUCTED ON (B)(6) 2017 WHERE A LEGION FEMORAL AND INSERT COMPONENT, AND A GENESIS II TIBIAL COMPONENT WERE IMPLANTED, A REVISION WAS PERFORMED ON (B)(6) 2023 DUE TO EARLY KNEE PROSTHESIS LOOSENING WITH INFLAMMATORY REACTION (SYNOVITIS) AND AN INTRAOSSEOUS CYST FORMATION (LOSS OF SUBSTANCE). THE PATIENT PRESENTED WITH A GAP IN THE RIGHT DISTAL FEMUR WITH LOOSENING OF THE FEMORAL IMPLANT. DURING THE REVISION SURGERY, A NEW TOTAL KNEE PROSTHESIS WAS FITTED AND A BONE GRAFT WAS PERFORMED. NO OTHER COMPLICATIONS WERE REPORTED. PATIENT'S CURRENT HEALTH STATUS WAS REPORTED TO BE GOOD.

  Patient problems: Cyst(s); Failure of Implant; Inadequate Osseointegration; Inflammation; Synovitis

  MAUDE report 17303064 ↗
• InjuryOct 25, 2022Degraded; Improper or Incorrect Procedure or Method; Degraded; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2019 , IT WAS IDENTIFIED THAT THE LGN PS HIGH FLEX XLPE SZ 3-4 10MM WAS DAMAGED AND THE COATING ON THE LEGION PS OXIN FEM SZ7 RT WAS COMPLETELY WORN OFF. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15665787 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEGION TKA HAD BEEN PERFORMED ON 2012, THE PATIENT EXPERIENCED AN INFECTION AND LOOSENING. THIS ADVERSE EVENT IS BEING SOLVED BY A TWO STAGE REVISION SURGERY, IN WHICH ALL THE IMPLANTS WERE REMOVED. DURING THE FIRST STAGE AN ANTIBIOTIC FEMUR WAS IMPLANTED ALONG WITH A POLY AND A TIBIA CR, ALSO AN ANTIBIOTIC NAIL WAS USED IN THE TIBIA. THESE COMPONENTS ARE DUE TO BE EXPLANTED DURING THE SECOND STAGE IN APPROXIMATELY 6 WEEKS. THIS IS AN ONGOING ISSUE, AND THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Unspecified Infection

  MAUDE report 14549574 ↗
• InjurySep 27, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2011, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 BECAUSE THE LEGION POSTERIOR STABILIZED OXINIUM FEMORAL SIZE 7 RIGHT WAS BROKEN. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12538223 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, IT HAS BEEN MADE A REVISION SURGERY DUE TO TIBIAL LOOSENING. THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM, GNS II NON-POR TIB SZ 7 RIGHT AND LEGION PS OXIN FEM SZ7 RT WERE EXPLANTED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11326539 ↗
• InjuryMay 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEVERE METALLOSIS.

  Patient problems: Injury

  MAUDE report 8604090 ↗
• InjuryAug 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Code Available

  MAUDE report 7815130 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY AND MANIPULATION DUE TO PAIN, STIFFNESS, MECHANICAL SYMPTOMS AND DYSTROPHIC SCAR TISSUE.

  Patient problems: No Code Available

  MAUDE report 7811486 ↗

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-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.
• 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.