Legion 71431909Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556537329), received between Aug 7, 2020 and Oct 17, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

9 other recalls cover devices cleared under the same FDA submission (K081111, K162775); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A LGN RK HK OFFSET COUPLER TRIAL STD 4MM WAS DEFECTIVE. THE DISTAL END UNSCREWS WHEN IT SHOULD NOT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471291 ↗
• MalfunctionAug 28, 2022Device Contamination with Body Fluid; Detachment of Device or Device Component; Device Contamination with Body Fluid; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA, THE LGN RK HK OFFSET COUPLER TRIAL STD 4MM, FELL APART AND HAD OLD DRY BLOOD INSIDE. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307920 ↗
• MalfunctionDec 30, 2021Separation Problem; Separation Problem

  IT WAS REPORTED THAT, THE SPRING OF ALGN RK HK OFFSET COUPLER TRIAL STD 4MM CAME OUT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120502 ↗
• MalfunctionMay 7, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INNER HEX ON A LGN RK HK OFFSET COUPLER TRIAL STD 4MM IS STRIPPED. AS THIS WAS NOTICED DURING INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794726 ↗
• MalfunctionApr 29, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE LGN RK HK OFFSET COUPLER TRIAL STD 4MM COULD NOT TIGHTEN DOWN. AS THIS WAS NOTICED UPON INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744126 ↗
• MalfunctionApr 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSPECTION FOR A TOTAL KNEE ARTHROPLASTY THE LEGION REVISION HINGE OFFSET COUPLER TRIAL STANDARD 4 MM WAS NOTICED WITH A BIO BURDEN. SMITH AND NEPHEW BACKUP DEVICE AVAILABLE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742451 ↗
• MalfunctionApr 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSPECTION FOR A TOTAL KNEE ARTHROPLASTY THE LEGION REVISION HINGE OFFSET COUPLER TRIAL STANDARD 4 MM WAS NOTICED WITH A BIO BURDEN. SMITH AND NEPHEW BACKUP DEVICE AVAILABLE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742446 ↗
• MalfunctionApr 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSPECTION FOR A TOTAL KNEE ARTHROPLASTY THE LEGION REVISION HINGE OFFSET COUPLER TRIAL STANDARD 4 MM WAS NOTICED WITH A BIO BURDEN. SMITH AND NEPHEW BACKUP DEVICE AVAILABLE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742437 ↗
• InjuryMar 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE LGN RK HK OFFSET COUPLER TRIAL STD 4MM WAS USED, BUT THE SCREW IN THE COUPLER FOR CHANGING THE DIRECTION WAS TIGHTENED, THEREFORE THE SURGEON COULD NOT OPENED THE SCREW, SO THE LGN OFFSET COUPLER TRIAL 4MM WAS USED. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN, USING A SMITH-NEPHEW DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449960 ↗
• MalfunctionFeb 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION, THE THREADED END OF THE LGN RK HK OFFSET COUPLER TRIAL STD 4MM WAS NOTICED TO BE STRIPPED. A BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376964 ↗
• MalfunctionJan 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA, IT WAS NOTICED THAT HEX HEX SCREW WAS STRIPPED. INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250131 ↗
• MalfunctionAug 7, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSIDE SCREW OF THE LEGION RK HK OFFSET COUPLER TRIAL STD 4MM SEEMED STRIPPED: IT WOULD NOT TIGHTEN OR LOOSEN WHEN SCREWDRIVER WAS INSERTED. A BACK-UP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE. ISSUE WAS NOTICED IN LAB; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10379818 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081111, K162775. 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-2625-2017 · May 30, 2017 · Terminated
  LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
• Z-2624-2017 · May 30, 2017 · Terminated
  LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
• 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-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-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