LEGION 71434487Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556488454), received between Jun 22, 2021 and Dec 6, 2024 — classified as 2 injuries, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2024Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF THE LEGION HK 4.75 HEX TORQUE WRENCH ADAPT BROKE INSIDE OF HINGE IMPLANT. IT IS CURRENTLY STUCK. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW. NO INJURIES WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860980 ↗
• InjuryOct 12, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A REVISION SURGERY OF A NON-S+N DEVICE, IT WAS OBSERVED THAT A LEGION HINGE 4.75MM HEX TORQUE WRENCH ADAPTOR WAS STRIPPED DUE TO NORMAL WEAR AND TEAR. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 12619440 ↗
• MalfunctionJun 22, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, TWO LEGION HK 4.75 HEX TORQUE WRENCH ADAPT BROKE ((B)(4)) AND ONE LEGION HK 4.75MM HEX DRIVER ((B)(4)) HAD THE HANDLE LOOSE. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038916 ↗
• MalfunctionJun 22, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, TWO LEGION HK 4.75 HEX TORQUE WRENCH ADAPT BROKE ((B)(4)), AND ONE LEGION HK 4.75MM HEX DRIVER ((B)(4)) HAD THE HANDLE LOOSE. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038915 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY TWO LEGION HK 4.75 HEX TORQUE WRENCH ADAPT ((B)(4)) BROKE, AND THE HANDLE ON ONE LEGION HK 4.75MM HEX DRIVER ((B)(4)) CAME LOOSE. INSTRUMENTS OUTSIDE PATIENT. SURGERY WAS PERFORMED WITH BACK-UP DEVICES. INSTRUMENTS WERE EXTERNAL TO THE PATIENT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038906 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY TWO LEGION HK 4.75 HEX TORQUE WRENCH ADAPT ((B)(4)) BROKE, AND THE HANDLE ON ONE LEGION HK 4.75MM HEX DRIVER ((B)(4)) CAME LOOSE. INSTRUMENTS OUTSIDE PATIENT. SURGERY WAS PERFORMED WITH BACK-UP DEVICES. INSTRUMENTS WERE EXTERNAL TO THE PATIENT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038905 ↗

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