LEGION 71434455Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010550200), received between Nov 20, 2020 and Mar 23, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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.

• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT, A LGN 2.5MM HEX SCRWDRVR WAS DISCOVERED BROKEN OFF. AS THIS WAS NOTICED UPON SET-UP OR INSPECTION FOR A TKA SURGERY, THE PATIENT WAS NOT INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866680 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE LGN 2.5MM HEX SCRWDRVR BROKE WHILE PUTTING TOGETHER THE TIBIA AND STEM IMPLANT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388664 ↗
• MalfunctionJul 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A LEGION 2.5MM HEX SCREWDRIVER WAS FOUND STRIPPED. SURGERY WAS COMPLETED WITH A BACKUP DEVICE INSTEAD, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125558 ↗
• MalfunctionJun 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS FOUND THAT TWO (2) LGN 2.5MM HEX SCRWDRVR ARE STRIPPED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922446 ↗
• MalfunctionJun 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS FOUND THAT TWO (2) LGN 2.5MM HEX SCRWDRVR ARE STRIPPED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922434 ↗
• MalfunctionMar 29, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A KNEE REVISION, THE SMALL HEX WRENCH FOR SET SCREWS OF A LEGION REVISION IS WORN AND BROKEN. IT WAS STRIPPED WHEN TRYING TO TIGHTEN SET SCREWS. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586751 ↗
• MalfunctionMar 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TKA SURGERY, WHILE THE LEGION 2.5MM HEX SCREWDRIVER WAS INSIDE THE PATIENT, THE DEVICE STRIPPED. THE PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT INJURY TO THE PATIENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580424 ↗
• MalfunctionNov 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LGN 2.5MM HEX SCRWDRVR WAS FOUND WORN. S&N BACKUP AVAILABLE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879540 ↗

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