LEGION 71423246Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556032343), received between Dec 14, 2022 and Dec 19, 2023 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K073325, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A LEFT TKA SURGERY, THE PATIENT EXPERIENCED A MEDIAL PARTIAL MEDICAL COLLATERAL LIGAMENT AVULSION INTRAOPERATIVELY. THIS ADVERSE EVENT WAS SOLVED WITH A SMALL FRAGMENT SCREW. PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Bone Fracture(s); Damage to Ligament(s)

  MAUDE report 18357872 ↗
• InjuryJun 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A TKA WAS PERFORMED ON (B)(6) 2023, BECAUSE THE PATIENT HAD ARTHROFIBROSIS AND EXPERIENCED STIFFNESS. A LGN POROUS CR FEM SZ 6L WAS IMPLANTED, AND ON WEEK SIX POSTOPERATIVELY, IT WAS NOTICED THE PATIENT COULD NOT FLEX THE KNEE BEYOND 90 DEGREES, THEREFORE THE PROCEDURE DID NOT SOLVE THE PATIENT'S CONDITION. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY AND WAS SCHEDULED FOR A MUA PROCEDURE, ON (B)(6) 2023. PATIENT NOT YET RECOVERED.

  Patient problems: Arthrofibrosis; Loss of Range of Motion; Scar Tissue

  MAUDE report 17102157 ↗
• InjuryDec 14, 2022Adverse 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) 2018, THE PATIENT EXPERIENCED A FUNGAL INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 IN WHERE A LGN POROUS CR FEM SZ 6L, A GNS II RESURF PAT 35MM, A LGN XLPE DISHED ISRT SZ 5-6 11MM AND A GNS II CMT TIB SIZE 5 {} LEFT WERE EXPLANTED, AND A SPACER WAS PUT IN. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fungal Infection

  MAUDE report 15976128 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073325, K230653. One submission often covers many models, so check the product and lot details in each record.

• 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