LEGION 71431806Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010547385), received between Apr 1, 2024 and Apr 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A REVISION KNEE PROCEDURE PERFORMED ON (B)(6) 2024 TO REMOVE A TKA SYSTEM FROM ANOTHER COMPANY, THE SURGEON REQUIRED THE USE OF AUGMENTS FOR THE FEMUR AND TIBIA. WHILE ASSEMBLING THE FEMORAL POSTERIOR AUGMENT, THE DOCTOR REALIZED THERE WAS DIFFICULTY IN SECURING THE SCREW. IT WAS THEN NOTICED THAT PART OF THE SCREW OF A LGN SCW POS WEDGE TRIAL10M SZ5-6LG HAD COME AWAY AND WAS LEFT IN THE LGN OX CONSTRAIN FEMORAL TRIAL 6 LT. THE DOCTOR WAS ABLE TO COMPLETE THE USE OF THE TRIAL WHILE THE SCREW PART WAS STILL ATTACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A NON-SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016766 ↗

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