LEGION 71421387Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556030004), received between Nov 22, 2017 and Jul 20, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED HK SLEEVE BREAKAGE AFTER AROUND FOUR YEARS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022, TO EXCHANGE THE LEGION HK 15MM BOLT - SLEEVE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15069995 ↗
• InjurySep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND INSTABILITY. BOLT AND SLEEVE WERE REMOVED IN ORDER TO REPOSITION THE COMPONENTS, HINGE FEMORAL AND TIBIAL COMPONENTS WERE CEMENTED IN SITU. ONCE THE COMPONENTS WERE REMOVED, IT WAS NOTICED THAT THE SLEEVE WAS BENT, ATTEMPTING TO STRAIGHTEN THE HINGE, SLEEVE TAB BROKE COMPLETELY OFF. THERE WAS NO BACKUP OR REPLACEMENT AVAILABLE; SURGEON IMPLANTED THE BROKEN SLEEVE AGAIN USING FORCEPS. HINGE BOLT SUCCESSFULLY INSERTED AND TIGHTENED.

  Patient problems: Pain

  MAUDE report 9137585 ↗
• 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 7279462 ↗
• InjuryNov 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTION A WEEK AFTER HE UNDERWENT UNKNOWN PROCEDURE, WEEKS LATER ON (B)(6), HE WAS HOSPITALIZED DUE TO CELLULITIS ON LEFT ANTERIOR LEG.

  Patient problems: Cellulitis

  MAUDE report 7054729 ↗

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-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-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-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