LEGION 71421216Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00885556030059), received between May 8, 2018 and May 7, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Adverse 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) 2012, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN 13 YEARS POST PRIMARY IMPLANTATION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH A PRIMARY PATELLA RESURFACING IN LEFT KNEE WITH TOTAL KNEE REPLACEMENT IN SITU WAS PERFORMED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 21977998 ↗
• 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 LEFT REVISION SURGERY IN 2009 DUE TO OSTEOARTHRITIS IN RETAINED JOINT SPACE. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.4 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED ARTHROFIBROSIS 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: Loss of Range of Motion

  MAUDE report 20333210 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED ARTHROFIBROSIS, LIMITED ROM 15º-40º. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 12475044 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT A PATIENT HAS HAD RECURRENT DISASSOCIATION OF THE XLPE LINER FROM TIBIAL COMPONENT, IN A LEGION TKA. SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE FEMORAL COMPONENT, TIBIAL BASEPLATE AND POLY INSERT WERE EXPLANTED. THE PATELLAR COMPONENT WAS LEFT IN PLACE. UPON REVISION, IT WAS NOTICED THAT THE INNER SYNOVIUM WAS STAINED BLACK FROM METALLOSIS. THE POLY COMPONENT WAS FOUND DISENGAGED AND SUBLUXED. THE FEMORAL COMPONENT WAS FOUND WORN FROM WHERE IT WAS ENGAGING AGAINST THE TIBIAL COMPONENT. THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 AND IS COVERED UNDER (B)(4).

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 12387847 ↗
• MalfunctionMay 21, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT, ON (B)(6) 2020, 5 PIECES OF LEGION PS OXIN FEM SZ6 LT WAS SENT FOR MATERIAL REVIEW BOARD (MRB) EVALUATION DUE TO HANDLING/SURFACE DAMAGE CAUSED BY A STOPPAGE IN THE PASSIVATION MACHINE TRANSPORT SYSTEM. DISPOSITION INSTRUCTIONS IN THE NON-CONFORMANCE INDICATED THAT THE PRODUCT SHOULD BE RETURNED TO WET BLAST TO BE REWORKED. HOWEVER, WHEN REVIEWING THE PRODUCTION ORDER IN SAP, THE ORDER WAS NOT REWORKED BUT RETURNED TO THE PRODUCTION FLOOR UNDER THE ORIGINAL PRODUCTION ORDER. THIS IS BEING REPORTED FOLLOWING THE 21 CFR 803, A REMEDIAL ACTION IS BEING TAKEN, THERE WERE NO COMPLAINTS FOR THIS ISSUE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864553 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAS BOOKED THIS PATIENT FOR A REVISION OF HER KNEE REPLACEMENT, TAKING PLACE THE (B)(6) 2020. THE MOTIVE OF THIS REVISION SURGERY IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10911768 ↗
• InjuryAug 18, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A REVISION OF LEFT TKR WAS PERFORMED DUE TO PATIENT PRESENTING WITH PAIN WITH SLIGHT MALALIGNMENT/MALROTATION OF IMPLANT COMPONENTS. PRIMARY LEFT TKR WAS PERFORMED ON (B)(6) 2017. DURING REVISION SURGERY THE LEGION POSTERIOR STABILIZED OXINIUM FEMORAL SIZE 6 LEFT WAS REMOVED WITH RENOVATION KNEE GEAR. ORIGINAL OVAL 32MM PATELLA WAS RETAINED BY SURGEON. BONY CANALS AND SURFACES WERE PREPPED FOR A 5 LEFT LEGION REVISION FEMUR, 3 LEFT REVISION TIBIA WITH TIBIAL AND FEMORAL STEMS USED WITH OFFSET COUPLERS AND AUGMENTED FEMORAL COMPONENT. THE COMPONENTS WERE TRIALLED WITH ROM CHECK BEFORE IMPLANTATION. THE COMPONENT IMPLANTS USED WERE CEMENTED IN WITH PALACOS CEMENT AND CONSTRAINED 3-4 18MM INSERT IMPLANTED AFTER CEMENT CURING. THE WOUND WAS WASHED AND IRRIGATED, AND BETADINE/SALINE SOAKED, AND THEN CLOSED IN LAYERS AS PER STANDARD TECHNIQUE.

  Patient problems: Injury

  MAUDE report 10418679 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED DECREASED RANGE OF MOTION ON THE STUDY KNEE. THE EVENT WAS TREATED VIA SURGERY AND IS CONSIDERED RESOLVED.

  Patient problems: Injury

  MAUDE report 10077423 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS RECOVERING WELL POST SURGERY. HAD A PHYSIOTHERAPY SESSION WHERE THE KNEE WAS PUSHED DOWN TO INCREASE THE EXTENSION AND FROM THERE THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED DUE TO THIS INCIDENT.

  Patient problems: Pain

  MAUDE report 9363686 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO KNEE EFFUSION AND PAIN AN ADDITIONALLY AN ASPIRATION AND A CORTISONE INJECTION WERE GIVEN A MONTH AFTER.

  Patient problems: Injury; Pain

  MAUDE report 8349317 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER TWO UNSUCCESSFUL ASPIRATION ATTEMPTS DUE TO PAIN AND EFFUSION, A KNEE ARTHROSCOPY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8348458 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MEDICAL INTERVENTION IN WHICH IT WAS REQUIRED TO ASPIRATE THE LEFT KNEE TO PREVENT INFECTION IN THE PERIPROSTHETIC AREA

  Patient problems: No Code Available

  MAUDE report 7927784 ↗
• InjuryOct 1, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE LEFT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury

  MAUDE report 7922093 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY IN WHICH ALL IMPLANTS WERE REMOVED DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7921489 ↗
• InjuryMay 8, 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 FAULTY CEMENT AND MECHANISM.

  Patient problems: Injury

  MAUDE report 7494730 ↗

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.