GENESIS II 71440008Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010610393), received between Aug 21, 2020 and Oct 4, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT A GII DCF VARIABLE SZ GUIDE RT WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538150 ↗
• MalfunctionSep 21, 2022Break; Break

  IT WAS REPORTED THAT A GII DCF VARIABLE SZ GUIDE RT IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460937 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE GII DCF VARIABLE SZ GUIDE RT DIAL KNOB BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640565 ↗
• MalfunctionMar 24, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT, A GII DCF VARIABLE SZ GUIDE RT WAS BROKEN AND LOOSE. AS THIS WAS NOTICED AFTER A TKA SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13878839 ↗
• 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 11936688 ↗
• 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 11901699 ↗
• MalfunctionMay 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SURGERY, IT WAS NOTICED THAT THE SIZER EXTERNAL ROTATION NOB OF THE GII DCF VARIABLE SZ GUIDE RT WAS LOOSE AND NOT STAYING ON THE 3 DEGREE SLOT (MOVING FREELY AND NOT FUNCTIONING PROPERLY). THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS DELAYED FOR FEWER THAN 30 MINUTES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881800 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A GII DCF VARIABLE SZ GUIDE RT 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 11822041 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE GENESIS II DCF VARIABLE SIZE GUIDE RIGHT 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 11820482 ↗
• MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, THE GENESIS II DCF VARIABLE SIZE GUIDE RIGHT DIDN'T TURN PROPERLY (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 11807089 ↗
• MalfunctionApr 20, 2021Loose or Intermittent Connection; Fitting Problem; Loose or Intermittent Connection; Fitting Problem

  IT WAS REPORTED THAT DURING INSPECTION THE DIAL OF THE GENESIS II DCF VARIABLE SIZE GUIDE RIGHT WAS LOOSE AND UNABLE TO LOCK. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693313 ↗
• MalfunctionApr 20, 2021Loose or Intermittent Connection; Fitting Problem; Loose or Intermittent Connection; Fitting Problem

  IT WAS REPORTED THAT DURING INSPECTION THE DIAL OF THE GENESIS II DCF VARIABLE SIZE GUIDE RIGHT WAS LOOSE AND UNABLE TO LOCK. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693303 ↗
• 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. 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 11646915 ↗
• 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 11580419 ↗
• 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 11572451 ↗
• MalfunctionDec 18, 2020Material Separation; Naturally Worn; Material Separation; Naturally Worn

  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 11037903 ↗
• MalfunctionSep 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TKA THE DIAL OF THE GENESIS II DCF VARIABLE SIZE GUIDE RIGHT WAS LOOSE. PROCEDURE FINISHED WITH SAME DEVICE. UNKNOWN IF ANY HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10502188 ↗
• MalfunctionAug 21, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ITEM WAS FOUND TO BE LOOSE DURING A ROUTINE EFIP INSPECTION. NO CASE INVOLVED

  Patient problems: No Patient Involvement

  MAUDE report 10437725 ↗

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