LEGION 71421214Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556029121), received between Oct 26, 2017 and Jun 21, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

• InjuryJun 21, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, A PATIENT HAS BEEN EXPERIENCING ADVERSE REACTIONS WITH THE OXINIUM IMPLANTS, REPORTING ECZEMA AND ALLERGY-LIKE SYMPTOM. THE PATIENT CLAIMS TO HAVE PAIN AND DISCOMFORT. ALL INVESTIGATIONS-MR, INFECTION MARKERS, CT SCANS FOR MALROTATION ARE CLEAR. THE IGE IS RAISED AS MARKER FOR ALLERGIES. NEVERTHELESS, THE PATIENT CONTINUES TO EXPERIENCE INFLAMMATION AND SEVERE DISCOMFORT EVEN AFTER TREATMENT WITH NSAIDS, ANTI-INFLAMMATORIES, AND A SHORT COURSE OF STEROIDS.HEALTHWISE, PATIENT'S CURRENT HEALTH STATUS IS OK. SURGEON IS POTENTIALLY CONSIDERING REVISION OF THE OXINIUM IMPLANTS.

  Patient problems: Discomfort; Eczema; Hypersensitivity/Allergic reaction; Implant Pain; Inflammation

  MAUDE report 19589022 ↗
• MalfunctionJan 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, TWO HOURS AFTER THE PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT, IT WAS REALIZED THAT THE SALES REP COVERING HAD OPENED A LEFT LEGION PS OXIN FEM SZ4 AND A LEFT GNS II CMT TIB SIZE 2 {} INSTEAD OF RIGHTS. THE SURGEON AND OR DIRECTOR WERE THEN NOTIFIED OF THE MISTAKE. THE SURGEON DECIDED NOT TO REVISE. THE PATIENT IS PROGRESSING NORMALLY: HAS BEEN RELEASED FROM PHYSICAL THERAPY AND IS HEALING FROM SURGERY WITH NO REPORTED ISSUES AS OF WEEK 1 OF 2024. PATIENT REPORTS A REDUCTION IN PAIN AND IMPROVEMENT IN MOBILITY AND KNEE RANGE OF MOTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483704 ↗
• InjurySep 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2022, A LEFT TKA SURGERY WAS PERFORMED WITH LEGION AND GENESIS II IMPLANTS. ON (B)(6) 2023 THE PATIENT HAD TO UNDERGO A CLOSED KNEE MANIPULATION PROCEDURE, DUE TO POOR RECOVERY, EXCESSIVE SCAR TISSUE, CHRONIC PAIN AND INFLAMMATION, AND MOBILITY ISSUES. SINCE THE TKA, THE PATIENT HAS ALSO RECEIVED CONTINUOUS PHYSICAL THERAPY, BUT NO PROCEDURE HAS RESOLVED THEIR SYMPTOMS.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17675053 ↗
• InjurySep 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2022 , A LEFT TKA SURGERY WAS PERFORMED WITH LEGION AND GENESIS II IMPLANTS. ON (B)(6) 2023 THE PATIENT HAD TO UNDERGO A SYNOVECTOMY PROCEDURE, THE PATIENT HAS EXPERIENCED POOR RECOVERY, EXCESSIVE SCAR TISSUE, CHRONIC PAIN AND INFLAMMATION, AND MOBILITY ISSUES. SINCE THE TKA, THE PATIENT HAS ALSO RECEIVED A CLOSED KNEE MANIPULATION PROCEDURE AND CONTINUOUS PHYSICAL THERAPY, BUT NO PROCEDURE HAS RESOLVED THEIR SYMPTOMS.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17675045 ↗
• InjuryAug 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED LOOSENING OF THE LEGION PS OXIN FEM SZ4 LT. THIS ADVERSE EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE FEMORAL COMPONENT, THE INSERT AND THE TIBIAL BASEPLATE WERE EXPLANTED AND EXCHANGED WIH S+N IMPLANTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294248 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON OCTOBER 31, 2018 WHERE A LEGION PS OXINIUM SYSTEM HAD BEEN IMPLANTED DUE TO KNEE OSTEOARTHRITIS, PATELLOFEMORAL HYPERCOMPRESSION SYNDROME AND RETROPATELLAR OSTEOARTHRITIS. THE PATIENT EXPERIENCED NO RELIEF OF SYMPTOMS AND EXPERIENCED WORSENING RETROPATELLAR ARTHRITIS WITH LARGE CARTILAGE GLACES AND CONSIDERABLE PANNUS DEPOSITS. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2020, WHERE A PATELLOFEMORAL REPLACEMENT WAS PERFORMED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Arthritis

  MAUDE report 11616759 ↗
• InjuryOct 3, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT HAD HER PRIMARY TKA DONE ON (B)(6) 2019 AFTER WHICH SHE DAMAGED HER COLLATERAL LIGAMENTS.. REVISION CASE WAS DONE WITH STANDARD SURGICAL TECHNIQUE AND REMOVAL OF IMPLANTS IN SITU. CLINICAL AND INTRA-OPERATIVE FINDINGS SHOWED SEVERE DAMAGE TO THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS. THIS CAUSED INSTABILITY AND PRIMARY KNEE NEEDED TO BE REVISED TO A HINGE PROSTHESIS

  Patient problems: Injury

  MAUDE report 9151052 ↗
• InjuryMay 8, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEPTIC MOBILIZATION OF THE PROSTHESIS.

  Patient problems: Injury

  MAUDE report 8591243 ↗
• InjuryMay 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAS EXPERIENCED REDNESS, SWELLING AND MORE PAIN THAN EXPERIENCED WITH HER ORIGINAL KNEE THAT WAS REPLACED. ANOTHER SURGERY IS NEEDED.

  Patient problems: Injury

  MAUDE report 7528840 ↗
• InjuryOct 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6982049 ↗

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-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-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.