LEGION 71421936Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556031124), received between Nov 6, 2018 and Dec 20, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2024Adverse 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) 2023, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO DO A LATERAL RELEASE AND PATELLA BONE FACETECTOMY. THE LGN HK AXLE SZ 5 FEMUR AND AXLE PLUGS WERE REPLACED PRECAUTIONARY. AXLE APPEARS TO BE IN GOOD CONDITION AS IT WAS PUT IN BACK IN 2023. THE CURRENT HEALTH STATUS OF THE PATIENT IS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20995787 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA-REVISION SURGERY HAD BEEN PERFORMED ON 2016, THE PATIENT EXPERIENCED KNEE INSTABILITY. SURGEON THOUGHT IT COULD BE AN AXLE FAILURE. MODULAR IMPLANTS WERE REMOVED PER TECHNIQUE ON THE FEMUR. THE AXLE DID NOT APPEAR TO BE BENT AND THE HINGE LINK ASSEMBLY DID NOT APPEAR DAMAGED EITHER. THIS ADVERSE EVENT WAS ADDRESSED BY A SECOND-REVISION SURGERY ON (B)(6) 2023, IN WHICH THEY EXCHANGE THE FOLLOWING DEVICES: LGN HK AXLE SZ 5 FEMUR, LEGION HK 11MM BOLT - SLEEVE, LGN HK HYPEREXT STOP W/AX PLUG, LGN HK LINK ASSY SZ 2-5 FEM AND LEGION HK GD MOTION ISRT 11MM SZ 4-5 LT. AFTER PROCEDURE, SURGEON WAS SATISFIED WITH STABILITY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18229810 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION WHICH INCLUDES REMOVING ALL IMPLANTS AND INSERTING AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8043860 ↗

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-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-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-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
• 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