LEGION 71434401Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010550071), received between Apr 14, 2019 and Nov 8, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A REVISION SURGERY OF COMPETITOR DEVICES, THE PIN OF A (1) LEGION VALGUS GUIDE ASSEMBLY HAD FALLEN OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641871 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY THE SCREW OF ONE (1) LEGION VALGUS GUIDE ASSEMBLY POPPED LOOSE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353105 ↗
• MalfunctionMay 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALL BEARING OF A LEGION VALGUS GUIDE ASSEMBLY IS MISSING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545489 ↗
• MalfunctionMar 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A LEGION VALGUS GUIDE ASSEMBLY IS MISSING A BEARING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776293 ↗
• MalfunctionJan 5, 2022Misassembled; Misassembled

  IT WAS REPORTED THAT, A LEGION VALGUS GUIDE ASSEMBLY WAS AFFECTING THE CUT ANGLE OF THE FEMUR AND NEED TO GET THIS ITEM REPLACEMENT. NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172177 ↗
• MalfunctionNov 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LEGION VALGUS GUIDE ASSEMBLY BROKE. 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 12746697 ↗
• InjuryAug 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ASSEMBLY OF A REVISION SURGERY PIN FELL OUT. NO INJURIES OR DELAYS REPORTED. BACKUP DEVICE AVAILABLE. NO MORE INFORMATION PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8929001 ↗
• MalfunctionApr 14, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE INNER BALLS OF THE ASSEMBLY ARE BROKEN. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512682 ↗

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