GENESIS II 71441137Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 03596010484093), received between Mar 7, 2019 and Nov 7, 2025 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) GII MI IN SLT 3 MO TI CU BL RT BROKE WHILE THE CUT WAS BEING MADE. BREAKAGE OCCURRED OUTSIDE PATIENT. NO PIECES FELL INSIDE WOUND. THE PROCEDURE WAS COMPLETED USING THE RIGHT CUTTING GUIDE, BUT REVERSED, AFTER NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496432 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS NOTICED THAT THE KNOB OF THE GII MI IN SLT 3 MO TI CU BL RT HAD BROKEN OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935773 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT TWO (2) GII MI IN SLT 3 MO TI CU BL RT BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870423 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A GII MI IN SLT 3 MO TI CU BL RT BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725288 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A PIECE OF A GENESIS II MI IN SLT 3 MO TITANIUM CU BL RIGHT BROKE OFF DURING WASH AFTER CASE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720351 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, THE GII MI IN SLT 3 MO TI CU BL RT WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110463 ↗
• MalfunctionDec 3, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, A SCREW COULD NOT RE-ENGAGED IN THE GII MI IN SLT 3 MO TI CU BL RT. SURGERY HAD BEEN PERFORMED, WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924073 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT, A GII MI IN SLT 3 MO TI CU BL RT WAS FOUND DURING INSPECTION TO HAVE A PIECE BROKEN OFF, RENDERING IT UNUSABLE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789625 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487872 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII MI IN SLT 3 MO TI CU BL RT BROKE DURING USE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343216 ↗
• MalfunctionJul 15, 2021Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA, THE SCREW OF A GENESIS II MI IN SLT 3 MO TITANIUM CU BL RIGHT COMES OUT AND ITS BLADE GUARD IS BENT. THE PROCEDURE WAS FINISHED WITHOUT 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 12171095 ↗
• MalfunctionMar 15, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE GENESIS II MI IN SLT 3 MO TITANIUM CU BL RIGHT WAS RUSTY. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490182 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT, A GENESIS II MI IN SLT 3 MO TITANIUM CU BL RIGHT IS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366637 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE SCREW FROM THE TIBIA CUT BLOCK SNAPPED OFF THE BLOCK AS THE DOCTOR WAS TIGHTENING THE SCREW ON THE ROD FROM THE TIBIA JIG. ((B)(4)) ALSO REPORTED ANOTHER INSTRUMENT MALFUNCTION WITH THIS CASE, THE REAMER SHAFT HAD A BROKEN RING ON IT THAT WOULD NOT ALLOW IT TO LOCK ON TO THE ACTUAL REAMER. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326437 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, THE GENESIS II MI IN SLT 3 MO TITANIUM CU BL RIGHT WAS DISCOVERED TO BE BROKEN. SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO PATIENT INVOLVED. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269562 ↗
• MalfunctionJan 30, 2021Break; Break

  IT WAS REPORTED THAT THE CONNECTION KNOB ON GEN II RIGHT CUT BLOCK BROKE AFTER THE CASE, CAUSING THE NON-SPIKED FIXATION ROD TO NOT BE REMOVED. IT WAS NOTICED AFTER SURGERY IN CLEAN UP/STERILIZATION. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING THE SAME DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11256300 ↗
• MalfunctionJan 28, 2021Break; Break

  IT WAS REPORTED THAT THE ADJUSTMENT KNOB ON GENESIS II MI IN SLT 3 MO TITANIUM CU BL RIGHT BROKE UPON CLEANING AND STERILIZATION AFTER TOTAL KNEE ARTHROPLASTY CASE, NO EFFECT ON PATIENT AS CASE WAS COMPLETED WITH PART AND WAS BROKEN AFTER FINISHED. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248416 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION GENESIS II MI IN SLT 3 MO TITANIUM CU BL RIGHT KNOB FELL OFF. NO CASE INVOLVED. 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 11088654 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT, DURING A TRAINING THE TIBIAL CUTTING BLOCK SCREW BROKE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11072107 ↗
• MalfunctionDec 20, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICES WERE FOUND CRACKED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11043125 ↗
• MalfunctionNov 27, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAS A PREMATURE WEAR OF ALL METAL PARTS. NO PATIENT INVOLVED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10913066 ↗
• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT AFTER TOTAL KNEE ARTHROPLASTY IN SPD DEPARTMENT THE DEVICE WAS NOTICE WITH THE SCREW IN PIECE BROKEN. NO INJURY O HARM REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10655301 ↗
• MalfunctionSep 21, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING TKA A PIN STUCK IN THE CUTTING BLOCK. IT IS UNKNOWN HOW THE PROCEDURE FINISHED. UNKNOWN IF OCCURRED A SURGICAL DELAY. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10563856 ↗
• MalfunctionNov 20, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE KNOB BROKE OFF AFTER THE SURGEON ATTACHED IT TO THE REMAINDER OF THE JIG SYSTEM. A 0-30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349650 ↗
• MalfunctionMay 21, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SURGERY THE BLOCKS WERE NOT CUTTING EVENLY. NO DELAY WAS REPORTED AND THE PROCEDURE FINISHED FREEHANDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628574 ↗

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