LEGION 71421377Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556414880), received between May 29, 2019 and Nov 27, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K081111, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY TKA LEFT SURGERY IN 2020 DUE TO UNSPECIFIED REASONS. DURING THE SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 4.13 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED A PATELLA MALTRACKING OR INSTABILITY THAT REQUIRED A TKA 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 20791052 ↗
• InjuryNov 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT SURGERY IN 2017 DUE TO DEGENERATIVE ARTHRITIS. DURING THE SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.05 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A TKA 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 20736134 ↗
• InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN 2014 DUE TO INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0,12 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 20536414 ↗
• InjuryJun 4, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN 2018 DUE TO DEGENERATIVE ARTHRITIS. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 4,02 YEARS AFTER THIS PROCEDURE, THE PATIENT SUFFERED FROM IMPLANT DISSOCIATION AND REQUIRED A 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 Dislocation

  MAUDE report 19459163 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A TKA ON (B)(6) 2018, THE PATIENT SUFFERED A FRACTURED DISTAL FEMUR UPON FALLING OUT OF BED. IN RESPONSE TO THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN WHICH ALL COMPONENTS WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 18066148 ↗
• InjuryJul 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE LGN HK FEM ASSEMBLY SZ 7 LT BROKE AND THE SCREW OF THE LEGION HK GD MOTION ISRT 13MM SZ 6-7 LT LOOSENED. THIS WAS TREATED BY A REVISION SURGERY ON 19-JUN-2023, IN WHICH THE LGN HK FEM ASSEMBLY SZ 7 LT AND THE LEGION HK GD MOTION ISRT 13MM SZ 6-7 LT WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 17278244 ↗
• MalfunctionMay 5, 2022Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LGN HK FEM ASSEMBLY SZ 7 LT WOULD NOT ALLOW THE LEGION HK SLEEVE TO BE INSERTED INTO THEM. HOWEVER, THEY MANAGED TO PASS THE SLEEVE THROUGH THE LINK ASSEMBLY BY LIGHTLY IMPACTING IT. SURGERY WAS RESUMED, WITH A DELAY OF GREATER THAN 30 MINUTES, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292306 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT A 2-STAGE REVISION SURGERY TO ADDRESS A DEEP INFECTION, THE PATIENT SUFFERED FROM POST-OPERATIVE BLEEDING ANEMIA. THE ADVERSE EVENT WAS TREATED WITH TRANSFUSION OF 2 ERYTHROCYTE CONCENTRATES WITH NO FURTHER COMPLICATIONS.

  Patient problems: Anemia

  MAUDE report 13343730 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REVISION SURGERY FOR A PERIPROSTHETIC SPIRAL FRACTURE OF THE FEMUR WAS PERFORMED IN (B)(6) 2021 (COVERED UNDER (B)(4)), A STRAIN OF E. COLI AND S. HAEMOLYTICUS WAS DETECTED IN THE PATIENT IN (B)(6) 2021. THE ISSUE REQUIRED ANTIBIOTIC THERAPY. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 13343657 ↗
• InjuryOct 28, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT FELL AND THE LINK MECHANISM OF A LGN HK FEM ASSEMBLY SZ 7 LT BROKE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE LGN HK FEM ASSEMBLY SZ 7 LT WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall

  MAUDE report 12708953 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEGION IMPLANT ON THE LEFT SIDE ON (B)(6) 2019, THE PATIENT THE PATIENT STARTED EXPERIENCING A HAEMARTHROSIS OF THE KNEE ON (B)(6) 2019; RIVAROXABAN RESTARTED WHEN SWELLING STARTED. CLEXANE WAS GIVEN, AND ANTIBIOTICS /APIXABAN WITHHELD. THIS ADVERSE EVENT HAS NOT BEEN TREATED AND IS, THEREFORE, ONGOING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11773604 ↗
• InjuryOct 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ONE YEAR AFTER IMPLANTATION IT WAS FOUND THAT THE CONNECTION SCREW 15MM WAS LOOSE. BOLD INSERT AND AXIS FROM THE FEMUR SIZE 7 WERE REPLACED.

  Patient problems: Injury

  MAUDE report 10722871 ↗
• InjuryMay 29, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO SET SCREW BACKED OUT OF THE POLY. THERE WAS A SIGNIFICANT DEFECT ON MEDIAL ASPECT OF FEMUR SO THE DECISION WAS MADE TO CHANGE THE FEMUR. NO PROCEDURE DETAILS REPORTED.

  Patient problems: Injury

  MAUDE report 8651801 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081111, 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-1105-2018 · Feb 1, 2018 · Terminated
  smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis;
• Z-2090-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthrit
• Z-2095-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthriti
• Z-2092-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthrit
• Z-2091-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthri
• Z-2093-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthri
• Z-2094-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis