LEGION 71434330Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010549808), received between Sep 15, 2020 and May 31, 2022 — classified as 7 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2022Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT DURING A TKA SURGERY THE LGN INTRA ALIGNMENT GUIDE LOCKING PIECE WAS MISSING. THE GUIDE COULD NOT BE LOCKED TO THE IM ROD. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548493 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE LGN INTRA ALIGNMENT GUIDE WAS BROKEN. SINCE IT WAS NOTICED DURING INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14363887 ↗
• MalfunctionOct 6, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE KNOB OF A LGN INTRA ALIGNMENT GUIDE FELL OUT, BROKE OFF AND GOT LOST. 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 12582762 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT THE LEGION INTRA ALIGNMENT GUIDE WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846530 ↗
• MalfunctionApr 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE DEVICE IS STRIPPED. THIS WAS NOTICED DURING SET UP OR INSPECTION. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693304 ↗
• MalfunctionApr 13, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING TKA SURGERY, THE LEGION INTRAMEDULLARY ALIGNMENT GUIDE GOT JAMMED AND DID NOT TIGHTEN TO THE REAMER. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655907 ↗
• MalfunctionSep 15, 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 Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10538412 ↗

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