GENESIS II 71440007Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 03596010610386), received between Jun 23, 2020 and Oct 15, 2022 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• MalfunctionOct 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE EXTERNAL ROTATION DIAL OF TWO (2) GII DCF VARIABLE SZ GUIDE LT ARE BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612597 ↗
• MalfunctionMay 22, 2022Break; Break

  IT WAS REPORTED THAT THE GII DCF VARIABLE SZ GUIDE LT WAS NOTICED TO BE BROKEN. IT IS UNKNOWN WHEN THE DEVICE BROKE OR IF THERE WAS A PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 14467123 ↗
• MalfunctionJun 22, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A GENESIS II DCF VARIABLE SIZE GUIDE LEFT DID NOT LOCK PROPERLY. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038912 ↗
• InjuryJun 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA, THE LOCKING MECHANISMS OF TWO (2) GII DCF VARIABLE SZ GUIDES LT BROKE DURING SURGERY WHILE INSTRUMENTS WERE INSIDE THE PATIENT. IT IS UNKNOWN IF THE DEVICES SUFFERED A BREAK OR IF THE LOCKING MECHANISM WAS NOT WORKING AS INTENDED. NO SURGICAL DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978183 ↗
• InjuryJun 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA, THE LOCKING MECHANISMS OF 2 GII DCF VARIABLE SZ GUIDES LT BROKE DURING SURGERY WHILE INSTRUMENTS WERE INSIDE THE PATIENT. IT IS UNKNOWN IF THE DEVICES SUFFERED A BREAK OR IF THE LOCKING MECHANISM WAS NOT WORKING AS INTENDED. NO SURGICAL DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978071 ↗
• MalfunctionJun 4, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, IT WAS NOTICED THAT A GII DCF VARIABLE SZ GUIDE RT ((B)(4)) AND A GII DCF VARIABLE SZ GUIDE LT ((B)(4)) WERE LOOSE AND NOT WORKING PROPERLY. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING SMITH & NEPHEW BACK UPS. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936690 ↗
• MalfunctionMay 28, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, BOTH GENESIS II DCF VARIABLE SIZE GUIDE LEFT AND RIGHT WERE NOTICED TO BE LOOSE AND NOT WORKING PROPERLY. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11902197 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A GII DCF VARIABLE SZ GUIDE LT BROKE. INSTRUMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821666 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE GENESIS II DCF VARIABLE SIZE GUIDE LEFT BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED. 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 11820464 ↗
• MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, THE GENESIS II DCF VARIABLE SIZE GUIDE LEFT DIDN'T TURN PROPERLY BECAUSE IT WAS TOO LOOSE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807052 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE DIALS OF TWO GENESIS II DCF VARIABLE SIZE GUIDE LEFT WAS BROKEN. NO CASE INVOLVED THEREFORE NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693320 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE DIALS OF TWO GENESIS II DCF VARIABLE SIZE GUIDE LEFT WAS BROKEN. NO CASE INVOLVED THEREFORE NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693318 ↗
• MalfunctionApr 15, 2021Unstable; Incomplete or Inadequate Connection; Unstable; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, IT WAS FOUND THAT THE DIAL TO ADJUST THE GENESIS II DISTAL CUT FIRST VARIABLE SIZING GUIDE LEFT IS LOOSE. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671688 ↗
• MalfunctionApr 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SIZING GUIDE IS LOOSE. THE FAULT WAS NOTICED DURING USE, OUT SIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646913 ↗
• MalfunctionApr 2, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE INSPECTION BEFORE A TKA IT WAS NOTICED THAT THE GII DCF VARIABLE SZ GUIDE LT HAS THE SCREW FOR HEIGHT ADJUSTMENT DEFECTIVE. UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610534 ↗
• 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 11580415 ↗
• MalfunctionMar 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE DIAL OF THE GENESIS II DISTAL CUT FIRST VARIABLE SIZING GUIDE LEFT IS VERY LOOSE. NO INJURY OR DELAY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572405 ↗
• MalfunctionMar 3, 2021Misassembly During Maintenance/Repair; Misassembly During Maintenance/Repair

  IT WAS REPORTED THAT, AFTER SURGERY IT WAS NOTICED THAT THE GII DCF VARIABLE SZ GUIDE LT HAS A SCREW THAT KEEPS COMING LOOSE. NO CASE REPORTED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408640 ↗
• MalfunctionJan 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING INSPECTION, VARIABLE SIZE GUIDE DEVICE WAS LOOSE. NO CASE INVOLVED; THEREFORE, 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 11151407 ↗
• MalfunctionDec 18, 2020Material Separation; Material Separation

  IT WAS INITIALLY REPORTED THAT THIS INSTRUMENT WAS NOT FIT FOR USE. NO CASE INVOLVED. HOWEVER, BASED ON A PRELIMINARY ASSESSMENT CONDUCTED BY THE MANUFACTURER, IT WAS DETERMINED THAT THIS EVENT NEEDS TO BE RE-CLASSIFIED AS REPORTABLE AS THE KNOB WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037932 ↗
• MalfunctionDec 9, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A GENESIS II DCF VARIABLE SIZE GUIDE LEFT WAS LOOSENED AND WAS NOT ABLE TO KEEP CORRECT EXTERNAL ROTATION. THIS OCCURRED DURING A TKA PROCEDURE, INSTRUMENT INSIDE THE PATIENT. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979074 ↗
• MalfunctionNov 20, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE BOTTOM DIAL OF THE DEVICE WAS LOOSE AND WOULD NOT STAY HOLD STEADY AT 3 DEGREES OF EXTERNAL ROTATION. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10875050 ↗
• MalfunctionOct 22, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE GENESIS II DCF VARIABLE SIZE GUIDE LEFT HAS SEVERAL ISSUES: SCREWING MECHANISM/LOCKING SYSTEM OF THE HEIGHT/SIZE SETTING IS NOT LOCKING PROPERLY. FAULT IN THE DEVICE WAS NOTICED DURING USE. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED. NO INJURY TO THE PATIENT WAS REPORTED. 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 10719303 ↗
• MalfunctionAug 26, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT WHILE USING THE LEFT SIZING GUIDE DURING A TKA PROCEDURE, THE SURGEON NOTED THE EXTERNAL ROTATION PADDLES THAT SEAT UNDER THE POSTERIOR FEMORAL CONDYLES WOULD NOT STAY IN PLACE. THE GUIDE APPEARS TO BE LOOSE AND IS UNABLE TO BE TIGHTENED. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH THE SAME DEVICE. NO DELAY. NO INJURIES OR 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 Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10457387 ↗
• MalfunctionAug 11, 2020Break; Break

  IT WAS REPORTED THAT THIS 3 DEGREE VARUS VALGUS ADJUSTMENT KNOB IS BROKEN. RELEVANT INFORMATION THAT DESCRIBES THE PRODUCT PROBLEM AND/OR ADVERSE EVENT WAS NOT PROVIDED. IT IS UNKNOWN WHETHER THE INCIDENT HAPPENED OR NOT IN A SURGICAL ENVIRONMENT OR AS CONSEQUENCE OF A SURGERY. 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 10393961 ↗

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