Legion 71431908Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556537312), received between Dec 28, 2020 and Apr 28, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 2 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 11742436 ↗
• 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 2 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 11742421 ↗
• 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 2 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 11742419 ↗
• MalfunctionApr 26, 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 2 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 11729569 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE LOCKING MECHANISM ON TWO LEGION REVISION HINGE OFFSET COUPLER TRIALS STANDARD 2MM WAS NOTICED TO BE STRIPPED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624930 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE LOCKING MECHANISM ON TWO LEGION REVISION HINGE OFFSET COUPLER TRIALS STANDARD 2MM WAS NOTICED TO BE STRIPPED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624923 ↗
• MalfunctionMar 14, 2021Break; Break

  IT WAS REPORTED THAT THE LEGION RK HK OFFSET COUPLER TRIAL STD 2MM IS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478823 ↗
• MalfunctionFeb 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS ARE STRIPPED. THE PROCEDURE FINISHED WITH THE SAME DEVICE. UNKNOWN WHEN THE INCIDENT OCCURRED, IF OCCURRED A SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326216 ↗
• MalfunctionJan 12, 2021Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE LGN RK HK OFFSET COUPLER TRIAL STD 2 MM WOULD NOT LOCK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155866 ↗
• MalfunctionDec 28, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT , DURING INSTRUMENT INSPECTION, IT WAS FOUND THAT THIS COUPLER DOESN'T LOCK RELIABLY, MAKING IT UNFIT FOR FURTHER USE. NO CASE OR PATIENT WAS AFFECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077384 ↗

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-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-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-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-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-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