GENESIS II 71441147Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010497185), received between Dec 10, 2018 and May 16, 2024 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (9 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE DOCTOR WAS UNABLE TO REMOVE ONE PIN AFTER COMPLETING HIS DISTAL CUT WITH ONE (1) GII MIS DCF DISTAL CUT BLK. HE WAS ABLE TO PULL THE GUIDE OFF THE BONE BY HAND AFTER SUCCESSFULLY REMOVING THE OTHER TWO FIXATION PINS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19337285 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY A GII MIS DCF DISTAL CUT BLK WAS DISLODGED IN THE PINHOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18075511 ↗
• MalfunctionMay 30, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT, THE GII MIS DCF DISTAL CUT BLK WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539308 ↗
• MalfunctionMar 2, 2022Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS NOTICED THAT THE GII MIS DCF DISTAL CUT BLK IS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656408 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT A GENESIS II MIS DCF DISTAL CUT BLK IS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087338 ↗
• MalfunctionJun 16, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING TKA SURGERY AND UPON INSERTION OF A TROCAR PIN INTO A GII MIS DCF DISTAL CUT BLK, THE PIN GOT JAMMED AND UNREMOVABLE. A PIN CUTTER WAS USED BY THE SURGEON TO CUT THE JAMMED PIN FROM THE CUTTING BLOCK, THIS WHILE THE DEVICE WAS HANDLED OUTSIDE OF THE PATIENT. A DIFFERENT HOLE OF THE BLOCK WAS USED IN ORDER TO CONTINUE WITH THE PROCEDURE AS NO BACKUP TRAY INCLUDING THIS DEVICE WAS AVAILABLE. A DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012477 ↗
• MalfunctionJun 1, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, PRIOR TO TKA, IT WAS NOTICED THAT THE SMOOTH PIN IS STUCK IN GII MIS DCF DISTAL CUT BLK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916806 ↗
• MalfunctionMay 17, 2021Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA, THE GENESIS II MINIMALLY INVASIVE DISTAL CUT FIRST DISTAL CUTTING BLOCK DID NOT LOCK PROPERLY. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY USING A BACK-UP DEVICE. PATIENT WAS NOT IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832538 ↗
• MalfunctionMay 17, 2021Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA, THE GENESIS II MINIMALLY INVASIVE DISTAL CUT FIRST DISTAL CUTTING BLOCK DID NOT LOCK PROPERLY TO THE DVF ALIGNMENT U. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY USING A BACK-UP DEVICE. PATIENT WAS NOT IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832522 ↗
• MalfunctionApr 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, A GENESIS II MIS DCF DISTAL CUT BLOCK WAS BROKEN, THE PIN WAS STUCK IN THE CUTTING BLOCK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655882 ↗
• MalfunctionApr 11, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING TKA SURGERY, THE TROCAR PIN OF THE GENESIS II MINIMALLY INVASIVE DISTAL CUT BLOCK LODGED IN THE PIN HOLE. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646911 ↗
• MalfunctionMar 25, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A TKA SURGERY, IT WAS NOTICED THAT THE GII MIS DCF DISTAL CUT BLK HAD A PIN STUCK IN IT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572480 ↗
• 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 11572444 ↗
• MalfunctionMar 14, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DISTAL FEMORAL CUTTING BLOCK DID NOT STAY LOCKED INTO THE ALIGNMENT GUIDE. PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478821 ↗
• MalfunctionFeb 28, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING SURGERY, WHILE INSIDE THE PATIENT, THE DISTAL FEMORAL CUTTING BLOCK KEPT STICKING ON THE VALGUS ALIGNMENT GUIDE AND WAS DIFFICULT TO TAKE APART. PROCEDURE CONTINUED WITH THE SAME DEVICE, WITH A DELAY OF LESS THAN 30 MINUTES AND NO INJURY. 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 11391057 ↗
• MalfunctionFeb 23, 2021Failure to Disconnect; Connection Problem; Failure to Disconnect; Connection Problem

  IT WAS REPORTED THAT, THE TROCAR PIN HOLES OF A GENESIS II MIS DCF DISTAL CUT BLK ARE SNAGGING PINS AND IMPEDING EXTRACTION. NO CASE REPORTED; 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 11367217 ↗
• MalfunctionJan 27, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE GENESIS II MIS DCF DISTAL CUT BLK WAS RETURNED WITH A TROCAR PIN STUCK IN ONE OF THE ALIGNMENT HOLES. THE PIN IS COLD WELDED AND CAN NOT BE REMOVED. NO CASE REPORTED; 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 11235635 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR TKA PROCEDURE, WAS NOTED THAT THE GENESIS II MIS DCF DISTAL CUT BLK WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH & NEPHEW BACKUP DEVICE. 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 11111998 ↗
• MalfunctionDec 29, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA A PIN GOT STUCK IN THE GENESIS II MIS DCF DISTAL CUT BLK. PROCEDURE FINISHED WITH SAME DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087038 ↗
• MalfunctionDec 29, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE THE TROCAR PIN GOT STUCK IN FEMORAL CUTTING BLOCK. BACKUP USED TO COMPLETE THE CASE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086733 ↗
• MalfunctionDec 10, 2020Corroded; Corroded

  IT WAS REPORTED THAT, A GENESIS II MIS DCF DISTAL CUT BLK WAS STARTING TO RUST. NO CASE REPORTED; 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 10982783 ↗
• MalfunctionNov 23, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING SURGERY, THE HOLES IN THE GENESIS II MIS DCF DISTAL FEMORAL CUTTING BLOCK HAVE BECOME CROSS-THREADED AND PINS ARE GETTING STUCK IN THE HOLES. DEVICE WAS STILL USED TO COMPLETE THE PROCEDURE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886443 ↗
• MalfunctionNov 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS NOTICED THAT THE HOLES ON THE DISTAL CUTTING BLOCK HAD BURRS AND PINS COULD NOT GO THRU EASILY. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10844115 ↗
• MalfunctionNov 2, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING SURGERY, THE PIN COULD NOT INSERT INTO THE HOLE OF THE DISTAL CUTTING BLOCK GUIDE. SO THE DOCTOR TRIED TO PULL THE PIN FROM THE HOLE OF THE GUIDE, BUT THE PIN WAS STUCK INTO THE HOLE. FINALLY THE PIN WAS PICKED BY THE PLIERS. THIS INCIDENT CAUSED 10 MINUTES DELAY. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE AND A DIFFERENT HOLE OF THE GUIDE. THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10772503 ↗
• MalfunctionSep 17, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A TKA, THE DISPOSABLE PIN OF GENESIS II MIS DCF DISTAL CUT BLK WAS FOUND TO BE JAMMED; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10550183 ↗

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