LEGION 71421218Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556031179), received between Jan 29, 2018 and Nov 5, 2022 — classified as 6 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, REMOVE TKR AND PATELLA AND LEGION REVISION TKR INSERTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15740874 ↗
• InjuryDec 28, 2021Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT HAD RECURRENT PATELLA SUBLUXATION/ DISLOCATION. IT WAS PREVIOUSLY TREATED WITH EXTENSOR MECHANISM REPAIR 1.5 YEARS AGO, BUT IT FAILED. AT THE TIME, SURGEON ATTRIBUTED THE PROBLEM TO THE LEGION PS OXINIUM FEMORAL SZ 8 LEFT (-1) FOR POSSIBLE MALROTATION. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE LEGION PS OXINIUM FEMORAL SZ 8 LEFT ((B)(4)) AND THE GII PS HIGH FLEXION INSERT SZ 7-8 13MM ((B)(4)) WERE EXCHANGED. MORE EXTERNAL ROTATION WAS APPLIED TO THE FEMORAL COMPONENT AND TIBIAL TUBERCLE TRANSFER AND EXTENSOR MECHANISM REPAIR WERE PERFORMED. ALSO, IT WAS NOTED THAT PRIOR TO PRIMARY TKR, PATIENT HAD BOTH FEMORAL AND TIBIAL OSTEOTOMIES. SURGEON COMMENTED THAT THIS MAY BE ATTRIBUTABLE TO OUTCOMES, AS ANATOMY 'DISTORTED'. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 13095087 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN APPROXIMATELY 6 MONTHS AFTER TOTAL KNEE REPLACEMENT. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12924045 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TOTAL KNEE REVISION SURGERY WAS PERFORMED BECAUSE THE POLY AND PATELLA IMPLANT FAILED FROM A PREVIOUS TOTAL KNEE SURGERY. MEDWATCH USER REPORT MW5093972.

  Patient problems: Injury

  MAUDE report 10077387 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE PATIENT DUE TO PAIN AND SWELLING. NO DELAY REPORTED. IMPLANTS REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Injury

  MAUDE report 8140250 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY DUE TO ON GOING PAIN, SURGEON SUGGESTED TIBIA APPEARED INTERNALLY ROTATED. NO SIGNS OF INFECTION.

  Patient problems: Pain

  MAUDE report 7224078 ↗

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
• 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.