NA 71565657Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010412003), received between Aug 11, 2020 and Oct 10, 2022 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE THE REPL BIT FOR TORQUE WRENCH BROKE WHILE ATTEMPTING TO DISMANTLE. AS THIS HAPPED AFTER SURGERY, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569243 ↗
• MalfunctionMay 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TKR REVISION SURGERY, IT WAS NOTICED THAT THE REPL BIT FOR TORQUE WRENCH WAS STRIPPED. THERE IS NO INFORMATION THAT THE REVISION SURGERY WAS DUE TO A FAULTY SMITH AND NEPHEW IMPLANT. THE PATIENT OUTCOME IS UNKNOWN. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE AND NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904593 ↗
• MalfunctionMay 13, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING A TKA SURGERY THE REPL BIT FOR TORQUE WRENCH IS WEAR THE TORQUE BIT HAS ROUNDED, THEREFORE UNABLE TO TORQUE BOLTS. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817295 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER TKA PROCEDURE, IT WAS NOTICED THAT THE REPL BIT FOR TORQUE WRENCH IS STRIPPED AND NEED TO BE REPLACED. THERE WAS NO PATIENT INVOLVED WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624859 ↗
• MalfunctionMar 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TKA SURGERY, WHILE THE REPL BIT FOR TORQUE WRENCH WAS BEING USED INSIDE THE PATIENT, THE DEVICE STRIPPED. PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11540505 ↗
• MalfunctionMar 11, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING A TKA WAS NOTICED SIX REPL BIT FOR TORQUE WRENCH BLUNTED. THERE WAS NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458375 ↗
• MalfunctionMar 11, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING A TKA WAS NOTICED SIX REPL BIT FOR TORQUE WRENCH BLUNTED. THERE WAS NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458373 ↗
• MalfunctionMar 11, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING A TKA WAS NOTICED SIX REPL BIT FOR TORQUE WRENCH BLUNTED. THERE WAS NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458372 ↗
• MalfunctionMar 11, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING A TKA WAS NOTICED SIX REPL BIT FOR TORQUE WRENCH BLUNTED. THERE WAS NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458371 ↗
• MalfunctionMar 11, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING A TKA WAS NOTICED SIX REPL BIT FOR TORQUE WRENCH BLUNTED. THERE WAS NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458369 ↗
• MalfunctionMar 11, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING A TKA WAS NOTICED SIX REPL BIT FOR TORQUE WRENCH BLUNTED. THERE WAS NO DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458368 ↗
• MalfunctionNov 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE REPL BIT FOR TORQUE WRENCH 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 10879658 ↗
• InjuryNov 5, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING TKA SURGERY, WAS NOTICED THAT THE REPL BIT FOR TORQUE WRENCH IS DAMAGED AND COULDN¿T TIGHTEN THE SCREW. THE PROCEDURE WAS FINISHED WITH A CHANGE IN SURGICAL TECHNIQUE, USING A NON TORQUE 3.5 HEX WAS USED TO TIGHTEN SCREW. THERE WAS NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10794881 ↗
• MalfunctionOct 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEVICE IS COMPLETELY STRIPPED AND IS NOT USABLE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10742066 ↗
• MalfunctionAug 11, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE REPL BIT FOR TORQUE WRENCH WAS FOUND TO BE STRIPPED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10394215 ↗

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