LEGION 71423352Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556031230), received between Mar 31, 2022 and Nov 29, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K081111); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA-SECOND-REVISION SURGERY, SURGEON WAS USING A SCREW DRIVER TO ACT AS AN AXLE AND THE LEGION HK GD MOTION ISRT 11MM SZ 4-5 LT SEEMED TO BE STABLE. THE SURGEON THEN REMOVED THE BOLT, SLEEVE AND HINGE MECHANISM. HOWEVER, TO DISCONNECT THE TAPER HE NEEDED TO TAKE A BONE TAMP AND HIT THE METAL HINGE MECHANISM TO BREAK THE TAPER. IT WAS VERY HARD TO DO THIS AND AT SOME POINT AFTER TAKING THOSE MODULAR COMPONENTS OUT, THE TIBIA POPPED UP, WHICH IT SHOULD NOT. ULTIMATELY THE SCREW THAT LOCKS IT INTO THE TIBIA WAS BROKEN. THE SURGEON HAD TO USE A METAL CUTTING BUR TO REMOVE THE REMAINING SCREW LEFT IN THE TIBIAL IMPLANT. THIS WAS DONE SUCCESSFULLY AND A NEW INSERT WAS OUT IN AND ALL THE MODULAR PIECES WERE REIMPORTED PER THE TECHNIQUE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229891 ↗
• InjuryMar 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED INSTABILITY ON THE IMPLANTS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE WHOLE LEGION HK SYSTEM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 13961597 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081111. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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