LEGION 71434333Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010549839), received between Oct 30, 2019 and Mar 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT A LEGION STYLUS 1MM IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666290 ↗
• MalfunctionAug 26, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A SCREW FELL OUT OF ONE LGN STYLUS 1MM. INCIDENT OCCURRED WITH INSTRUMENTS OUTSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED. THE INVESTIGATION FOUND THAT THE DEVICE WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375272 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, WHILE THE INSTRUMENTS WERE BEING USED OUTSIDE OF THE PATIENT, THE LEGION STYLUS 1 MM BROKE. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH AN AVAILABLE SMITH AND NEPHEW BACK UP DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820382 ↗
• MalfunctionOct 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY THE SCREW CAME OUT DURING PROCEDURE. THE PART WAS REMOVED FROM THE PATIENT. A SMITH & NEPHEW BACK UP WAS AVAILABLE. THERE WAS A 1-2 MINUTE DELAY IN PROCEDURE, BUT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258150 ↗

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