LEGION 71434465Recalls & reported problems
Smith & Nephew, Inc. · LEGION HINGE TIBIAL STABILIZING TOOL · Class 2
Quick summary
This Smith & Nephew Legion Hinge Tibial Stabilizing Tool is a surgical instrument used during knee replacement surgery. The 41 reports mostly describe parts of the tool breaking off during the operation — prongs, pegs, pins, or tips snapping away — and in a few cases pieces breaking loose or remaining in the patient. Reports mention 6 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00885556033098), received between Apr 19, 2018 and Jun 15, 2026 — classified as 6 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Break” (27 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.
Reports received per month
Most reported problems
Device problems
- Break27
- Fracture13
- Adverse Event Without Identified Device or Use Problem1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient2
- No Patient Involvement2
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
- Injury1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Fracture
IT WAS REPORTED THAT, DURING A HINGE KNEE SURGERY, THE PRONGS OF TWO (2) LEGION HINGE TIBIAL STABILIZING TOOL BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25498025 ↗MalfunctionJan 26, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA REVISION SURGERY (UNKNOWN IF FROM S+N IMPLANTS), THE TIP OF ONE (1) LEGION HINGE TIBIAL STABILIZING TOOL BROKE OFF FROM THE HANDLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177454 ↗MalfunctionJan 5, 2026Fracture
IT WAS REPORTED THAT, DURING A KNEE SURGERY, THE PEG OF THE LEGION HINGE TIBIAL STABILIZING TOOL, SNAPPED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23970185 ↗MalfunctionNov 3, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA REVISION SURGERY THE INDENT ON ONE (1) LEGION HINGE TIBIAL STABILIZING TOOL BROKE OFF. IT WAS RETRIEVED AND TOSSED OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460421 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) LEGION HINGE TIBIAL STABILIZING TOOL BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460338 ↗MalfunctionSep 16, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE PIN ON (1) LEGION HINGE TIBIAL STABILIZING TOOL BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOWN HOW SURGERY WAS COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23062895 ↗MalfunctionFeb 4, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, WHILE MAKING FINAL ADJUSTMENT OF THE IMPLANT WITH THE TORQUE WRENCH, ONE (1) LEGION HINGE TIBIAL STABILIZING TOOL PIN BROKE. THE PIECE WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED BY CHANGE IN SURGICAL TECHNIQUE WITHOUT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303727 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF A LEGION HINGE TIBIAL STABILIZING TOOL BROKE WHILE THE SURGEON WAS COUNTER TORQUING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, APPLYING A CHANGE IN THE SURGICAL TECHNIQUE. IT IS UNKNOWN IF THIS CAUSED ANY INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684275 ↗MalfunctionSep 8, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, THE PEG OF A LEGION HINGE TIBIAL STABILIZING TOOL BROKE OFF DURING USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166088 ↗MalfunctionSep 8, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, THE PEG OF A LEGION HINGE TIBIAL STABILIZING TOOL WHICH INSERTS INTO THE TIBIA BROKE OFF DURING USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166071 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE TIP OF A LEGION HINGE TIBIAL STABILIZING TOOL BROKE WHILE BEING USED. 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 18831076 ↗MalfunctionDec 23, 2023Break; Break
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) LEGION HINGE TIBIAL STABILIZING TOOL BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18389809 ↗MalfunctionSep 5, 2023Break; Break
IT WAS REPORTED THAT DURING TKA SURGERY, ONE (X1) LEGION HINGE TIBIAL STABILIZING TOOL BROKE WHILE HOLDING TIBIA. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17687772 ↗MalfunctionMay 24, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA REVISION, THE TIP OF A LEGION HINGE TIBIAL STABILIZING TOOL BROKE, WHILE TIGHTENING A BOLT, AND ALL BROKEN PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE SINCE THERE WAS NO BACK-UP AVAILABLE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16993645 ↗MalfunctionApr 21, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) LEGION HINGE TIBIAL STABILIZING TOOL BROKE AND GOT STUCK IN IMPLANT. NO SURGICAL DELAY WAS REPORTED; HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792409 ↗MalfunctionApr 17, 2023Break; Mechanics Altered; Break; Mechanics Altered
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LEGION HINGE TIBIAL STABILIZING TOOL DEVICE WOULD NOT TURN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALS THE TIP BROKE OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE DEVICE. THE DEVICE SHOWS SIGNIFICANT SIGNS OF WEAR AND USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16752435 ↗MalfunctionOct 6, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE TIP OF A LEGION HINGE TIBIAL STABILIZING TOOL BROKE OFF. IT IS UNKNOWN IF ANY OF THE BROKEN PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15553699 ↗MalfunctionSep 2, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A LEGION HINGE TIBIAL STABILIZING TOOL´S LITTLE TIP BROKE OFF WHILE USING TO TORQUE THE IMPLANT. HCP WAS USING THE DEVICE IN THE CORRECT WAY. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15345897 ↗MalfunctionAug 10, 2022Break; Break
IT WAS REPORTED THAT, THE METAL POINTY PIECE ON TOP OF THE LEGION HINGE TIBIAL STABILIZING TOOL IS CHIPPED OFF. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15200813 ↗InjuryMar 11, 2022Break; Break
IT WAS REPORTED THAT, DURING A REVISION SURGERY (UNKNOWN IF FROM S+N), THE SMALL ROUND EXTENSION ON THE LEGION HINGE TIBIAL STABILIZING TOOL BROKE WHILE TORQUEING THE POST BOLT ON FINAL IMPLANT INSIDE THE PATIENT. NO MORE THAN 150 IN-LB. OF TORQUE WAS BEING APPLIED AS READ DIRECTLY OFF TO THE TORQUEING WRENCH. SURGERY WAS RESUMED, WITH A DELAY OF FEWER THAN 30 MINUTES, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13734002 ↗MalfunctionDec 1, 2021Break; Break
IT WAS REPORTED THAT, THE LEGION HINGE TIBIAL STABILIZING TOOL WAS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912397 ↗InjuryNov 1, 2021Break; Break
IT WAS REPORTED THAT, DURING THE FINAL TIGHTENING OF THE HK BOLT OF A TKA, WHEN USING THE LEGION HINGE TIBIAL STABILIZING TOOL IN COMBINATION WITH THE TORQUE WRENCH, THE SMALL TOOTH ON THE STABILIZING TOOL THAT LOCKS INSIDE THE HK BASEPLATE SNAPPED OFF. THE PIECE THAT BROKE AWAY WAS LEFT TRAPPED INSIDE THE BASEPLATE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 12734082 ↗InjuryOct 28, 2021Break; Break
IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY WHILE TIGHTENING THE DEVICE INTO THE TIBIA, A LEGION HINGE TIBIAL STABILIZING TOOL SNAPPED OFF INSIDE THE PATIENT. THE PART THAT SNAPPED OFF WAS RETRIEVED WITH TWEEZERS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12715760 ↗MalfunctionFeb 3, 2021Break; Break
IT WAS REPORTED THAT, WHEN INSPECTING TRAYS,THE LEGION HINGE TIBIAL STABILIZING TOOL DEVICE WAS FOUND BROKEN. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11275612 ↗MalfunctionJan 13, 2021Break; Break
IT WAS REPORTED THAT THE PEG BROKE OFF IN A LEGION HINGE TIBIAL STABILIZING TOOL. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. IT IS UNKNOWN IF THERE WAS ANY DELAY. IT IS UNKNOWN WHICH PROCEDURE WAS PERFORMED AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11159357 ↗
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, ClassifiedLEGION 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 · TerminatedSmith+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 · Terminatedsmith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
- Z-1902-2018 · Apr 9, 2018 · Terminatedsmith&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
Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.