LEGION 71421205Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556030622), received between Aug 25, 2017 and Jul 20, 2023 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED SEPSIS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A LEGION PS OXIN FEM SZ5 RT, LGN PS HIGH FLEX XLPE SZ 3-4 11MM, GNS II CMT TIB SIZE 4 {} RIGHT AND A GNS II RESURF PAT 29MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 17368077 ↗
• InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT STARTED TO EXPERIENCE STIFFNESS AND LOSS OF RANGE OF MOTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN WHERE A LEGION PS OXIN FEM SZ5 RT AND LGN CR HIGH FLEX XLPE SZ 3-4 9MM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 16301727 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON 18-OCT-2021, THE PATIENT COMPLAINED OF KNEE PAIN DURING HIS FOLLOW UP ON 29-OCT-2021. THE DOCTOR REVIEWED AND OUT THAT THERE IS FRACTURE LINE ON THE BONE WHERE THE LEGION POSTERIOR STABILIZED OXINIUM FEMORAL SIZE 5 RIGHT WAS IMPLANTED. CURRENTLY PATIENT HAS KNEE DISCOMFORT.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12829571 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE FEMUR. NO PATIENT RECORDS, EXPLANTS, AND X-RAYS ARE AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9668861 ↗
• InjuryDec 10, 2018Adverse 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 INCREASED PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8146316 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT STATUS POST RIGHT TKA HAD BEEN EXPERIENCING AN MRSA INFECTION FOR WHICH SHE DID CONTINUE ON THE CHRONIC PROPHYLAXIS ANTIBIOTICS. DUE TO SWELLING AND THE PREVIOUSLY ORDERED LABORATORY STUDIES, AN ASPIRATION WAS PERFORMED. AFTER 1% LIDOCAINE WAS USED FOR ANESTHESIA PURPOSES, AN 18 GAUGE NEEDLE WAS USED TO ASPIRATE THE KNEE AND APPROXIMATELY 25-30 CC OF THIN SEROUS FLUID BLOOD TINGED WAS OBTAINED. SHE USED A KNEE IMMOBILIZER FOR AMBULATION ON THE RIGHT AND A REGULAR WALKER, SHE ALSO WAS PRESCRIBED WITH TRAMADOL .

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8134056 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2016, HAD BEEN TREATED WITH P.O. ANTIBIOTICS. SHE PRESENTED REDNESS AND SWELLING WITH SLOW HEALING AND POSSIBLE CELLULITIS AND DEEP INFECTION. HER KNEE JOINT WAS ASPIRATED FOR A 1CC OF BLOODY FLUID. SHE WAS ADMITTED TO THE HOSPITAL FOR IV ANTIBIOTICS, VANCOMYCIN WAS PRESCRIBED. SHE MAY HAD REQUIRED SURGICAL DEBRIDEMENT, IRRIGATION AND ANTIBIOTIC BEADS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8133194 ↗
• InjuryMar 19, 2018Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ASEPTIC LOOSENING AND MECHANICAL COMPLICATIONS OF THE DEVICE.

  Patient problems: Injury

  MAUDE report 7350121 ↗
• InjuryDec 20, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED A REVISION SURGERY OF SMITH AND NEPHEW KNEE IMPLANTS

  Patient problems: Injury

  MAUDE report 7134179 ↗
• InjuryAug 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO RESURFACE THE PATELLA.

  Patient problems: Injury

  MAUDE report 6835165 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY DUE TO KNEE PAIN.

  Patient problems: Pain

  MAUDE report 6819720 ↗

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-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.