LEGION 71421367Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556414927), received between Sep 13, 2017 and Nov 27, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY RIGHT TKA SURGERY IN 2020 DUE TO INSTABILITY WITH LATERAL PATELLAR DISLOCATION. DURING THIS SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 1.32 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 20791804 ↗
• InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2015 DUE TO INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.5 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 20539326 ↗
• InjuryOct 25, 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 2014 DUE TO INSTABILITY. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 1.7 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INFECTION 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: Medical device site infection

  MAUDE report 20536371 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 0.9 YEARS AFTER A REVISION TKA OF THE RIGHT KNEE IN WHICH A LEGION HK SYSTEM WAS IMPLANTED, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO INSTABILITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 19458954 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE IMPLANTATION OF A RIGHT LEGION HK SYSTEM ON (B)(6) 2020, THE PATIENT FELT A CRACK WHILE CHANGING PANTS ON (B)(6) 2020. AN UNDISPLACED PERI-PROSTHETIC FRACTURE ON THE MEDIAL CONDYLE WAS DIAGNOSED VIA CT AND X-RAYS. PHYSICAL THERAPY WAS SUSPENDED AND THE PATIENT WAS PLACED ON A SPLINT; HOWEVER, AS THE FRACTURE WAS DISPLACING, A REVISION SURGERY WAS PRESCRIBED. THE FEMORAL ASSEMBLY WAS REPLACED AND THREE WIRE CERCLAGES WERE INSTALLED ON (B)(6) 2020 TO ADDRESS THIS EVENT.

  Patient problems: Anemia; Bone Fracture(s)

  MAUDE report 18123195 ↗
• InjuryOct 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR PAIN AND INFLAMMATION. IT WAS DISCOVERED THAT THE PATIENT HAD AN INFECTION. ALL COMPONENTS WERE REVISED EXCEPT FOR THE PATELLA. THE PATIENT HAD UNDERGONE A WASHOUT A YEAR PRIOR TO THIS REVISION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9247974 ↗
• InjuryJan 10, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  LEGION HINGE STUDY; ID: (B)(6); SUBJECT: (B)(6): INTERTROCHANTERIC LEFT HIP FRACTURE. IT WAS REPORTED THAT PATIENT HAD AN INTERTROCHANTERIC LEFT HIP FRACTURE RESOLVED IN SURGICAL PROCEDURE. THE SURGEON CLAIMS THE HINGE SYSTEM TENDS TO BUCKLE WHICH MAY HAVE CAUSED THE FALL AND THE FEMORAL FRACTURE. BUCKLING IS FURTHER ATTRIBUTED TO LACK OF QUADRICEPS MUSCLE STRENGTH DUE TO LACK OF APPROPRIATE POST-OPERATIVE RECOVERY REGIMENT. ALSO, IT WAS STATED BY THE DOCTOR THAT S&N HINGE KNEE SYSTEM IS NOTED AS FUNCTIONING WELL AND REMAINS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8237914 ↗
• 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 7535267 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN MEDICAL INTERVENTION DUE TO WEIGHT BEARING PAIN AND SWELLING OF THE KNEE. SURGEON NOTED THAT ADVERSE EVENT MAY BE RELATED TO STUDY PROCEDURE.

  Patient problems: Swelling

  MAUDE report 6994901 ↗
• InjurySep 13, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO DISTAL THIGH PAIN. DURING THE REVISION IT WAS DISCOVERED THE FEMORAL IMPLANT WAS LOOSE.

  Patient problems: Injury; Pain

  MAUDE report 6861531 ↗

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-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
• 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-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