LEGION 71424046Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010546784), received between Sep 5, 2018 and Oct 25, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE (3) RIGHT REV FEMUR WITH 13X160 PRESSFIT STEM TRIALS WERE USED DURING TRIALING, THE SEATING WAS CORRECT, BUT DURING A TKA SURGERY PERFORMED ON (B)(6) 2023, UPON USAGE OF ACTUAL IMPLANTS IT SAT ROUGHLY 1CM PROUD AND WOULD NOT ADVANCE FURTHER. THE LGN PRESSFIT STEM 13MM X 160MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Failure of Implant

  MAUDE report 18008255 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR REVISION SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RANGE OF MOTION ISSUES, PRESENTING LOOSE EXTENSION AND TIGHT IN FLEXION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. THE FEMORAL COMPONENT, THE TIBIAL BASE PLATE, STEM AND THE TIBIAL INSERT WERE EXPLANTED. LEGION REVISION TIBIA AND FEMUR WERE IMPLANTED WITH FEMORAL DISTAL WEDGES AND A CONSTRAINED POLY INSERT. IT IS UNKNOWN CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 16325767 ↗
• InjurySep 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL PARTS WERE REMOVED AND REPLACED WITH CEMENT MOULDS FROM HERAEUS. NO MORE INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9073111 ↗
• MalfunctionMay 9, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING REVISION SURGERY THE CONSTRUCTED IMPLANTS WOULD NOT FIT PROPERLY IN PATIENT. MORE THAN 30 MINUTES OF DELAY WAS REPORTED AND BACKUP DEVICE WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597362 ↗
• InjuryOct 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REMOVE THE IMPLANTS FROM THE PATIENT DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8017378 ↗
• 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 7900976 ↗
• InjurySep 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY FO RIGHT KNEE WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7846496 ↗

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