LEGION 71434404Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010550170), received between Oct 9, 2020 and Oct 18, 2022 — classified as 14 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K121393); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A LGN 6 DEG VALG COL NTRAL S3-8 WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628570 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT A LEGION 6 DEG VALGUS COLLET NEUTRAL S3-8 BROKE DURING WASH. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490835 ↗
• MalfunctionMar 29, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A LEGION 6 DEGREE VALGUS COLLET NEUTRAL S3-8 HAS SEIZED UP AND IS NOT PROPERLY WORKING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934812 ↗
• MalfunctionOct 11, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A LEGION 6 DEG VALGUS COLLET NEUTRAL S3-8 NO LONGER ATTACHED TO NECESSARY INSTRUMENTS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606102 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION OR SET UP BEFORE A TKA SURGERY, THE LGN 6 DEG VALG COL NTRAL S3-8 WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922292 ↗
• MalfunctionMay 31, 2021Scratched Material; Physical Resistance/Sticking; Scratched Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT A LEGION 6 DEG VALG COL NTRAL S3-8 DIDN'T TWIST EASILY AND HAD HUGE GOUGE MARKS. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907849 ↗
• MalfunctionMay 6, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LGN 6 DEG VALG COL NTRAL S3-8 WAS STUCK IN THE LOCKED POSITION AFTER REPROCESSING. THE DEVICE WAS ABLE TO BE UNLOCKED BUT NO LONGER LOCKS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783728 ↗
• MalfunctionMay 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING INSPECTION PROCESS IT WAS NOTICED THAT THE LGN 6 DEG VALG COL NTRAL S3-8 HAD FROZEN TIGHT. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776973 ↗
• MalfunctionMar 25, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A TKA THE LGN 6 DEG VALG COL NTRAL S3-8 WILL NOT TURN. INSTRUMENTS OUTSIDE PATIENT. S&N BACKUP DEVICE AVAILABLE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572422 ↗
• MalfunctionMar 14, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, THE LGN 6 DEG VALG COL NTRAL S3-8 WON'T ACCEPT REAMER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478882 ↗
• MalfunctionJan 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING INSPECTION FOR A TKA PROCEDURE, THE COLLET WAS STUCK AND WOULDN'T MOVE. THERE WAS NO DELAY OR PATIENT HARM REPORTED. PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233198 ↗
• MalfunctionNov 26, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, IN A TOTAL KNEE ARTHROPLASTY, THE LEGION 6 DEG VALG COL NTRAL S3-8 DID NOT LOCK ONTO REAMER. IT IS UNKNOWN WHEN THE MALFUNCTION WAS NOTICED IF BEFORE, DURING OR AFTER PROCEDURE. SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912592 ↗
• MalfunctionNov 26, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE COLLET OF THE LEGION WON¿T SLIDE ONTO THE REAMERS SHAFT. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. 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 10909790 ↗
• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT THE ITEMS WERE FOUND BROKEN. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10657418 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a