LEGION 71424049Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010546814), received between Jul 6, 2017 and Oct 9, 2024 — classified as 6 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K072531, 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.

• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED AT AN UNKNOWN DATE ON 2021, A PERIPROSTHETIC INFECTION WAS IDENTIFIED IN THE PATIENT, CAUSING A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2024. IN THIS REVISION THE LGN PRESSFIT STEM 16MM X 160MM, LGN REV TIBIA BASE SZ 3 LT, LEGION CON ART INS 9MM SZ 3-4 AND AN UNKN LEGION KNEE IMPL WERE EXPLANTED. CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20407629 ↗
• InjuryApr 25, 2021Separation Problem; Separation Problem

  IT WAS REPORTED THAT, A LEFT KNEE REVISION SURGERY WAS PERFORMED AND THE LGN HK DIS FEM WDG SZ3 5MM HAS SEPARATED FROM THE LGN PRESSFIT STEM. SCREWS WERE NOT USED UPON IMPACTION OF FEMORAL STEM PER SURGEON¿S REQUEST. IT IS UNKNOWN WHETHER THE PRIMARY SURGERY WAS PERFORMED WITH SMITH-NEPHEW DEVICES OR THE CAUSE OF THE CURRENT REVISION SURGERY. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722106 ↗
• InjuryAug 26, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON 24/7/2019 DUE TO INSTABILITY. A ZIMMER PRODUCT WAS IMPLANTED INSTEAD. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: Injury

  MAUDE report 8929158 ↗
• InjuryNov 6, 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 INFECTION WHICH INCLUDES REMOVING ALL IMPLANTS AND INSERTING AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8044082 ↗
• InjurySep 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO STIFFNESS OF STUDY KNEE. NO SURGERY REQUIRED AND NO COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 7902206 ↗
• InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SUBJECT UNDERWENT REVISION SURGERY TO REPAIR FRACTURE. NO PRODUCT WAS REMOVED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 6691890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072531, 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