LEGION 71421631Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556414873), received between Aug 22, 2018 and Apr 9, 2024 — classified as 6 injuries.

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

• InjuryApr 9, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE COUPLING MECHANISM ON A LGN HK LINK ASSY SZ 2-5 FEM FRACTURED. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE WHOLE LEGION HINGE SYSTEM WAS REPLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Metal Related Pathology; Subluxation

  MAUDE report 19074011 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA PERFORMED ON 2014, THE PATIENT TWISTED THEIR KNEE AND FELT A POP. PATIENT EXPERIENCED INCREASE IN PAIN AND WAS UNABLE TO BEND KNEE (PATIENT STATES NO PREVIOUS COMPLAINTS BEFORE THE INCIDENT). THIS ADVERSE EVENT WAS TREATED BY REPLACING THE LGN HK LINK ASSY SZ 2-5 FEM ON (B)(6) 2022.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13591808 ↗
• InjurySep 17, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT, DURING SURGERY, THERE WAS A DOUBT IF THERE COULD BE A PART MISSING FROM THE CUSTOM IMPLANT, HOWEVER SURGEON WAS TOLD THAT THE DEVICE WAS CORRECT AND PROCEDURE CONTINUED AS PLANNED. ONCE THE PROCEDURE WAS CONCLUDED, INFORMATION WAS RECEIVED THAT THE BUSHING WAS MISSING FROM THE DEVICE. A REVISION SURGERY WAS PERFORMED NEXT DAY TO ADD THE HYPER EXTENSION BUSHING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 10551137 ↗
• InjuryFeb 12, 2019Fracture; Fracture

  A REVISION SURGERY WAS PERFORMED DUE TO A LEGION HK FEMORAL COMPONENT BROKEN.

  Patient problems: Injury

  MAUDE report 8334147 ↗
• 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 8043856 ↗
• InjuryAug 22, 2018Break

  IT WAS REPORTED THAT AS THE SURGEON WAS REMOVING THE FEMORAL COMPONENT FROM THE TIBIAL IT WAS NOTICED THAT THE ASSEMBLE WAS BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 7805051 ↗

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-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-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-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-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-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