GENESIS II 71440205Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010460424), received between May 7, 2018 and Feb 14, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN THAT HELD THE GOLD MOVING PIECE OF A GII SLT 3 MOD TIB CUTBLCK RT FELL OUT; THEREFORE, THE BLOCK COULD NOT BE TIGHTENED ON THE TIBIAL TOWER. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 18707185 ↗
• MalfunctionJan 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, THE GII SLT 3 MOD TIB CUTBLCK RT WAS BROKEN. THIS WAS IDENTIFIED DURING USE INSIDE THE PATIENT. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18513980 ↗
• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA PROCEDURE, THE GII SLT 3 MOD TIB CUTBLOCK RT PIN BROKE. AS THIS WAS NOTICED BEFORE PROCEDURE, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579942 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, IT WAS NOTICED THAT THE LEVER TO LOCK THE GII SLT 3 MOD TIB CUTBLCK RT WAS BROKEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192461 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA, THE LEVER OF A GENESIS II SLT 3 MOD TIB CUTBLCK RIGHT BROKE. THE PROCEDURE WAS FINISHED WITHOUT ANY SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103715 ↗
• MalfunctionMar 28, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION IT WAS NOTICED THAT THESE INSTRUMENTS SHOWED AN OVERABUNDANCE OF BIO-FILM THAT HAS BUILT UP ON THE INSTRUMENTS OVER THE YEARS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580411 ↗
• MalfunctionMar 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION IT WAS NOTICED THAT THESE INSTRUMENTS SHOWED AN OVERABUNDANCE OF BIO-FILM THAT HAS BUILT UP ON THE INSTRUMENTS OVER THE YEARS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572448 ↗
• MalfunctionJan 25, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHILE USING A GII SLT 3 MOD TIB CUTBLCK RT, THE CUTTING BLOCK LEVER FELL OFF AND THE PIN FELL OUT. THIS OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227560 ↗
• MalfunctionDec 30, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LOCKING MECHANISMS HAVE BECOME WORN OUT AND ARE DIFFICULT TO USE. NO PATIENT INVOLVED IN THE CASE. 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 11097759 ↗
• MalfunctionJul 16, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO SURGERY, DURING INSTRUMENT INSPECTION, WAS FOUND THAT THE GENESIS II SLT 3 MOD TIB CUTBLCK LEFT HAS WORN OVER TIME. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

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

  MAUDE report 10283552 ↗
• MalfunctionJul 16, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO SURGERY, DURING INSTRUMENT INSPECTION, WAS FOUND THAT THE GENESIS II SLT 3 MOD TIB CUTBLCK RIGHT HAS WORN OVER TIME. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10283533 ↗
• InjuryMay 7, 2018Difficult To Position; Difficult To Position

  IT WAS REPORTED THAT DURING SURGERY IS DIFFICULT TO FIX TIBIAL CUTTING BLOCK IN CORRECT POSITION, SO THE SURGEON HAD TO PROCEED WITH A RECUT.

  Patient problems: Injury

  MAUDE report 7489665 ↗

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