LEGION 71421364Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556414941), received between Feb 17, 2018 and May 15, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Difficult to Insert; Nonstandard Device; Difficult to Insert; Nonstandard Device

  IT WAS REPORTED THAT DURING A REVISION OF FREEMAN SAMUELSON TKR SURGERY, ONE (1) LEGION HK 11MM BOLT SLEEVE (BATCH 23CTM0045B) COULD NOT BE INSERTED PAST THE POLYETHYLENE OF THE HYPEREXTENSION STOP AND LINK OF THE FEMORAL COMPONENT (1) LGN HK FEM ASSEMBLY SZ 4 RT. AFTER REPEATED ATTEMPTS, A SECOND SLEEVE WAS OPENED TO DETERMINE IF THERE WAS AN ISSUE; HOWEVER, THE SAME FAULT OCCURRED WITH ONE (1) LEGION HK 11MM BOLT SLEEVE (BATCH 21JTM0038C). ON CAREFUL EXAMINATION, IT WAS DETERMINED THAT THE POLYETHYLENE IN THE HYPEREXTENSION STOP AND LINK OF THE FEMORAL COMPONENT WAS RESTRICTING THE SLEEVE FROM PASSING. THE LEGION HK 11MM BOLT SLEEVE WAS FORCED THROUGH USING A MALLET, WHICH REMOVED SOME POLYETHYLENE AND ALLOWED FOR FULL INSERTION OF THE SLEEVE. THE BOLT WAS THEN INSERTED SUCCESSFULLY, AND THE IMPLANTS WERE LOCKED. THE FEMORAL COMPONENT HAD ALREADY BEEN CEMENTED INTO THE FEMUR, AND REMOVAL WAS DEEMED UNFEASIBLE. ADDITIONALLY, NO ALTERNATIVE IMPLANT OF THE SAME SIZE WAS AVAILABLE. REPORTEDLY, THIS INCIDENT APPEARED TO HAVE RESULTED FROM A MANUFACTURING ISSUE WITH THE HYPEREXTENSION STOP AND LINK OF THE FEMORAL COMPONENT, AS THERE WAS EXCESS POLYETHYLENE OBSTRUCTING THE SLEEVE PASSAG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025487 ↗
• 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 EIGHTEEN MONTHS AFTER THIS PROCEDURE, THE PATIENT EXPERIENCED JOINT INSTABILITY OR PATELLA MALTRACKING 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: Insufficient Information; Joint Laxity

  MAUDE report 16223440 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED CONTOURED SCLEROTIC BORDER AROUND THE PROSTHESIS IN THE RIGHT KNEE ON (B)(6) 2021. THIS ADVERSE EVENT HAS NOT BEEN SOLVED.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 11968434 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED SWELLING AND REDNESS IN THE RIGHT KNEE. THE CAUSE OF THE SWELLING AND REDNESS IS UNKNOWN. THE PATIENT WAS PRESCRIBED TO TAKE REST AND MEDICATION THERAPY.

  Patient problems: Swelling

  MAUDE report 8334141 ↗
• InjuryOct 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A LATERAL CONDYLE FRACTURE THAT WAS TREATED WITH A SURGICAL PROCEDURE. THE EVENT IS ALREADY RESOLVED.

  Patient problems: Injury

  MAUDE report 8002262 ↗
• InjuryFeb 17, 2018Mechanical Problem; Mechanical Problem

  REVISION OF INSERT AND LEGION HINGE MECHANISM DUE TO INSTABILITY OF DE KNEE. PATIENT WAS WALKING AND SUDDENLY THE KNEE FELT UNSTABLE AND SHE WASN¿T ABLE TO WALK FURTHER. SHE DIDN¿T FALL OR INJURED HERSELF IN ANY WAY. WE OPENED THE KNEE AND FOUND SOME METALIZED TISSUE. REMOVING THE BOLT WAS VERY EASY. WE WEREN¿T ABLE TO REMOVE THE SLEEVE WITHOUT FIRST DETACHING THE HINGE MECHANISM. SO WE REMOVED THE MECHANISM ACCORDING THE SURGICAL TECHNIQUE. BECAUSE THE SLEEVE WAS STILL IN THE LGN HK LINK ASSY SZ 2-5 FEM WE WEREN¿T ABLE TO REMOVE THE LGN HK LINK ASSY SZ 2-5 FEM. FINALLY WE TURNED THE LGN HK LINK ASSY SZ 2-5 FEM 180 DEGREES AND UNSCREWED THE INSERT. WITH SOME FORCE, WE MANAGED TO GET THE LGN HK LINK ASSY SZ 2-5 FEM AND SLEEVE OUT OF THE TIBIA. WE SAW SOME BLACK RESIDUE ON THE TIBIA BASE AT THE POSITION OF THE INSERT SCREW. IT LOOKED LIKE METALIZED RESIDUE AS WELL.

  Patient problems: Joint Disorder

  MAUDE report 7279463 ↗

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-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-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-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-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-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