LEGION 71421217Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556030882), received between Jan 17, 2020 and Jul 30, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD PRIMARY TKA SURGERY WITH MEDACTA IMPLANTS ON (B)(6) 2024, AND DUE TO INFECTION, WAS CONVERTED TO CEMENT SPACER ON (B)(6) 2024 AND REPLACED WITH SMITH AND NEPHEW IMPLANTS ON (B)(6) 2024 ONCE THE INFECTION SETTLED. AFTER THAT TKA REVISION, THE PATIENT EXPERIENCED AN INFECTION WHICH WAS TREATED BY A SECOND STAGE REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LEGION PS OXIN FEM SZ7 LT, THE LGN REV TIBIA BASE SZ 8 LT, THE LGN PRESSFIT STEM 14MM X 160MM AND THE UNKN LEGION TOTAL KNEE REV TIB INSERT UHMWPE WERE REMOVED AND REPLACED BY CEMENT SPACER. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22671026 ↗
• InjuryMar 12, 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) 2021 AND A FIRST REVISION SURGERY ON (B)(6) 2024 ((B)(4)), THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LEGION PS OXIN FEM SZ7 LT AND THE GNS II CON INS SZ5-6 11MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 21586731 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN ARTICULAR INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 14074624 ↗
• InjuryMay 12, 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 AND THE LEGION PS OXIN FEM SZ7 LT ((B)(4)), THE GNS II CMT TIB SIZE 7 LEFT ((B)(4)) AND THE GII PS HI FLEX ISRT SZ 7-8 13 ((B)(4)) WERE REMOVED FROM THE PATIENT AND REPLACED WITH SMITH AND NEPHEW DEVICES. THERE IS NOT SPECIFIC INFORMATION ABOUT THE NEW IMPLANTS THAT WERE USE IN THE REVISION SURGERY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 11814153 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT HAD AN UNSTABLE KNEE, WITH PAIN AND CLUNKING NOISE. A TOTAL REVISION SURGERY WAS PERFORMED TO EXPLANT ALL COMPONENTS. THE EVENT IS STILL ONGOING.

  Patient problems: Injury; Pain

  MAUDE report 10564425 ↗
• InjuryJan 17, 2020Adverse 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 LOOSENING, OSTEOLYSIS AND POSSIBLE CHANCE OF INFECTION. OSTEOLYSIS WAS CONFIRMED INTRAOPERATORY BY THE SURGEON. ALL COMPONENTS WERE REPLACED WITH CEMENT SPACERS. PRIMARY SURGERY PERFORMED ON (B)(6) 2012.

  Patient problems: Injury

  MAUDE report 9603198 ↗

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.