LEGION 71424047Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010546791), received between May 22, 2018 and Nov 11, 2021 — 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.

• InjuryNov 11, 2021Adverse 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) 2020, THE LEGION REV TIBIA BASEPLATE SZ 2 RIGHT ((B)(4)) BECAME LOOSE DUE TO SEPSIS, SO ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED TO REMOVE THE LEGION REV TIBIA BASEPLATE SZ 2 RIGHT ((B)(4)), THE GENESIS II CONSTRAINED ARTICULAR INSERT SIZE 1-2 18MM ((B)(4)), THE LEGION COBALT CHROME CONSTRAINED FEMORAL SIZE 4 RIGHT ((B)(6)) AND THE LEGION PRESSFIT STEM 14MM X 160MM (B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Sepsis

  MAUDE report 12796735 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT KNEE REPLACEMENT SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT WAS FINE EXCEPT THAT THERE WAS PAIN IN THE TIBIA, AT THE END OF THE STEM, CAUSED BY STRESS FORCES. AT THE 1.5 YEAR MARK IT WAS DETERMINED THAT THE STEM WAS CAUSING A COMPRESSION FRACTURE. PINS AND PLATES WERE PUT IN, BUT PAIN REMAINED. NOW, TWO (2) YEARS LATER, THE PATIENT HAS AGAIN A COMPRESSION FRACTURE GOING UP FROM THE STEM INTO THE PROSTHESIS, WHICH LIMITS MOBILITY.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain

  MAUDE report 12668088 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO POOR RANGE OF MOTION. SIGNIFICANT SOFT TISSUE WAS REMOVED. GOOD RANGE OF MOTION AT THE END OF THE SURGERY.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 10110420 ↗
• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A RIGHT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 8844601 ↗
• InjuryJun 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO KNEE JOINT PSEUDARTHROSIS. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE. THE PRODUCTS WAS RETURNED TO THE PATIENT AFTER THE SURGERY SO IT CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7564034 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ELEVEN DEVICES WERE REMOVED. PREVIOUS TO THIS REVISION SURGERY, A RIGHT KNEE WASHOUT AND A WOUND DEBRIMENT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7535272 ↗

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