LEGION 71434430Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010549372), received between May 31, 2019 and Apr 23, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY THE TIP OF ONE (1) LGN HOUSING CAM MODULE S7 CHIPPED OFF. 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 21895103 ↗
• MalfunctionOct 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE PIECE OF THE LGN HOUSING CAM MODULE S7 SNAPS INTO THE FEMUR TRIAL BROKE OFF. BROKEN PIECE WAS REMOVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894945 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT, A LGN HOUSING CAM MODULE S7 WAS BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659159 ↗
• InjuryJul 17, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY ONE OF THE SMALL TABS OF THE CAM MODULE TRIAL BROKE OFF. THIS HAPPENED OUTSIDE THE PATIENT. PIECES OF THE BROKEN DEVICE FELL INSIDE THE PATIENT AND ALL OF THEM WERE RECOVERED. NO DELAY. NO BACK UP NEEDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292515 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSTRUMENT BROKE. NO DELAY WAS REPORTED AND NO BACKUP DEVICE WAS AVAILABLE. DEVICE BROKE ON THE PATIENT'S INCISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660074 ↗

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