LEGION 71426004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010580399), received between Nov 11, 2021 and Nov 26, 2024 — classified as 9 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (K060742, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2020 DUE TO INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 3.61 YEARS AFTER THIS PROCEDURE, THE PATIENT SUFFERED FROM INSTABILITY AGAIN AND REQUIRED A TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 20788782 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TKA REVISION SURGERY IN 2018 DUE TO ASEPTIC LOOSENING. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 5 YEARS AFTER THIS PROCEDURE, THE PATIENT SUFFERED FROM ASEPTIC LOOSENING THAT REQUIRED A TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20738216 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2012 DUE TO UNSPECIFIED REASONS. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.82 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INFECTION THAT REQUIRED A 2 STAGE TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 20476118 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2011 DUE TO STIFFNESS. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0,37 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED ARTHROFIBROSIS AN REQUIRED ADDITIONAL SURGERY. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20439726 ↗
• InjuryOct 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TWO STAGE TKA RIGHT REVISION SURGERY IN 2011 DUE TO INFECTION. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0,44 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20391912 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TWO STAGE TKA RIGHT REVISION SURGERY IN 2011 DUE TO INFECTION. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0,10 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INFECTION THAT REQUIRED A WOUND DRAINAGE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 20391154 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2008 DUE TO ASEPTIC LOOSENING, BEARING WEAR, OSTEOLYSIS AND INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. ON (B)(6) 2010, THE PATIENT SUSTAINED A CANAL PERFORATION-TIBIA AND SMALL CRACK-FEMUR. IT IS UNKNOWN HOW THIS EVENT WAS TREATED. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 20321592 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO JOINT INSTABILITY AS PRIMARY DIAGNOSIS. APPROXIMATELY SIX (6) MONTHS AFTER THIS PROCEDURE, THE PATIENT EXPERIENCED JOINT INSTABILITY OF THE REVISED KNEE PROSTHESIS AND REQUIRED A SECOND REVISION. THE DATES IN WHICH THE INDEX SURGERY, FIRST REVISION AND SECOND REVISION TOOK PLACE ARE NOT KNOWN. IT IS ALSO UNKNOWN WHICH DEVICES WERE EXPLANTED AND/OR EXCHANGED DURING THE SECOND REVISION. THIS INCIDENT WAS IDENTIFIED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING TKA REVISION OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16223357 ↗
• 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)(4)) AND THE LEGION PRESSFIT STEM 14MM X 160MM ((B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Sepsis

  MAUDE report 12796698 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060742, 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
• Z-0589-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0591-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0590-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.