LEGION 71421234Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556030912), received between Sep 5, 2018 and Jan 7, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT HAD A LOOSE FEMORAL COMPONENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE LEGION CR OXIN FEM SZ4 LT WAS EXCHANGED TO A STEMMED CONSTRAINED FEMORAL OF THE SAME SIZE WITH A 10MM MEDIAL AUGMENT. CURRENT HEALTH STATUS OF PATIENT IS WELL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Aseptic loosening

  MAUDE report 21095220 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY WAS PERFORMED DUE TO INFECTION ON (B)(6) 2023, THE INFECTION DID NOT CALM DOWN. THIS ADVERSE EVENT WAS SOLVED WITH A 2ND REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH ALL IMPLANTS (GII DISHED INS SZ 3-4 11MM, LEGION CR OXIN FEM SZ4 LT, GNS II CMT TIB SIZE 4 LEFT AND GNS II RESURF PAT 26MM), WERE REMOVED AND CEMENT MOLD WAS IMPLANTED. HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16383376 ↗
• InjuryJul 15, 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 UNKNOWN DATE, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2021 BECAUSE THE FEMUR WAS PLACED IN AN INCORRECT VALGUS OF +12 DEGREES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12173276 ↗
• InjuryJun 27, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A LEFT TIBIAL BASEPLATE AND LEFT FEMORAL COMPONENT WERE IMPLANTED IN THE PATIENT'S RIGHT KNEE. THIS WAS NOTICED IN POST-OP XRAY. PATIENT ELECTED NOT TO GO BACK TO SURGERY.

  Patient problems: Injury

  MAUDE report 8742141 ↗
• InjuryMar 6, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  LEGION PRIMARY WITH VERILAST, (B)(4); TKR LOOSENING SUSPICION. IT WAS REPORTED THAT A YEAR AFTER TKR IT IS SUSPECTED THAT PATIENT HAS LOOSE COMPONENTS AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8394791 ↗
• InjuryOct 3, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED. MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH SEMITENDINOSUS ALLOGRAFT LEFT KNEE AND APPLICATION OF LONG LEG IMMOBILIZER. NO IMPLANTS REMOVED.

  Patient problems: No Information

  MAUDE report 7930856 ↗
• InjuryOct 3, 2018Unstable; Unstable

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury; Pain

  MAUDE report 7930692 ↗
• InjuryOct 2, 2018Mechanical Problem; Unstable; Mechanical Problem; Unstable

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7928556 ↗
• InjurySep 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. THE BASEPLATE, THE INSERT AND THE FEMORAL COMPONENT WERE EXPLANTED.

  Patient problems: No Information

  MAUDE report 7846726 ↗

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-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-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-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.