GENESIS II 71441144Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 03596010497161), received between Mar 22, 2018 and Apr 6, 2026 — classified as 13 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (15 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Mechanics Altered; Premature Separation

  IT WAS REPORTED THAT, BEFORE A TKA SURGERY, IT WAS NOTICED THAT ONE (1) GII MIS DCF ALIGN GDE EXHIBITED LOOSENESS AT THE JUNCTION WHERE THE DISTAL CUT BLOCK SLIDES INTO THE ALIGNMENT HOUSING, AS WELL THE THUMB PRESS INTENDED TO SECURE THE DISTAL CUT BLOCK IN PLACE, THE DISTAL CUT BLOCK FALLS OFF EVEN BEING FULLY ENGAGED. THE PROCEDURE WAS PERFORMED, AFTER A GREATER THAN 30 MIN DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791022 ↗
• MalfunctionJun 11, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SIDE SCREWS OF ONE (1) GII MIS DCF ALIGN GDE ARE WORE OUT WHICH MAKES THE 5° BUSHING FALL OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, HOWEVER IT IS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512769 ↗
• MalfunctionOct 25, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A GII MIS DCF ALIGN GDE BLOCK NO LONGER HOLDS POSITION. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT. UPON INSPECTION, IT WAS NOTICED THAT THE INSTRUMENTS WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668379 ↗
• MalfunctionJul 29, 2022Break; Break

  IT WAS REPORTED THAT, A GII MIS DCF ALIGN GDE WAS FOUND BROKEN. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136639 ↗
• MalfunctionJul 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GENESIS II DISTAL CUT FIRST ALIGNMENT GUIDE HAS NO PINS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052226 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT, AFTER GOING THROUGH DECONTAMINATION, THE TOP OF THE GII MIS DCF ALIGN GDE BROKE OFF. NO CASE INVOLVED. THEREFORE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859597 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II MINIMALLY INVASIVE DISTAL CUT FIRST ALIGNMENT GUIDE WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462791 ↗
• MalfunctionFeb 3, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE GII MIS DCF ALIGN GDE NO LONG SLIDES INTO PLACE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446586 ↗
• MalfunctionFeb 3, 2022Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE PINS OF THE GII MIS DCF ALIGN GDE FELL OUT OF ALIGNMENT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446281 ↗
• MalfunctionSep 21, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GENESIS II MINIMALLY INVASIVE DISTAL CUT FIRST ALIGNMENT GUIDE DID NOT LOCK DOWN THE DISTAL CUTTING BLOCK. SURGERY WAS RESUMED, WITHOUT ANY DELAY, BY MANUALLY ADJUSTING THE SURGICAL TECHNIQUE BY HOLDING THE DISTAL BLOCK IN PLACE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510957 ↗
• MalfunctionJun 29, 2021Break; Defective Device; Naturally Worn; Break; Defective Device; Naturally Worn

  IT WAS REPORTED THAT, A GII MIS DCF ALIGN GDE IS DAMAGED. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED. DURING THE INVESTIGATION PIECES WERE FOUND BROKEN OFF AND THE DEVICE SHOWS SIGNS OF EXTENSIVE WEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087767 ↗
• InjuryJun 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII MIS DCF ALIGN GDE WAS LOOSE AND THE DISTAL FEMORAL BLOCK CUT MUCH DEEPER THAN NEEDED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085060 ↗
• InjuryJun 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII MIS DCF ALIGN GDE WAS LOOSE AND THE DISTAL FEMORAL BLOCK CUT MUCH DEEPER THAN NEEDED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085013 ↗
• InjuryJun 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII MIS DCF ALIGN GDE WAS LOOSE AND THE DISTAL FEMORAL BLOCK CUT MUCH DEEPER THAN NEEDED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084999 ↗
• InjuryJun 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII MIS DCF ALIGN GDE WAS LOOSE AND THE DISTAL FEMORAL BLOCK CUT MUCH DEEPER THAN NEEDED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084946 ↗
• InjuryJun 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII MIS DCF ALIGN GDE WAS LOOSE AND THE DISTAL FEMORAL BLOCK CUT MUCH DEEPER THAN NEEDED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084917 ↗
• InjuryJun 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII MIS DCF ALIGN GDE WAS LOOSE AND THE DISTAL FEMORAL BLOCK CUT MUCH DEEPER THAN NEEDED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084892 ↗
• InjuryJun 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII MIS DCF ALIGN GDE WAS LOOSE AND THE DISTAL FEMORAL BLOCK CUT MUCH DEEPER THAN NEEDED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084873 ↗
• MalfunctionJun 2, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, THE LOCKING MECHANISM OF A GENESIS II MIS DCF ALIGN GDE WAS LOOSE AND WOULD NOT TIGHTEN 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 11918403 ↗
• MalfunctionMay 28, 2021Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED THAT DURING A TKA, THE GENESIS II MIS DCF ALIGN GD WOULD NOT LOCK AND HOLD INTO PLACE AS DESIGNED. 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 11904832 ↗
• MalfunctionMay 27, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, A GII MIS DCF ALIGN GDE ((B)(4)) HAD A BENT PIN, AND A GII MIS DCF ALIGN GDE ((B)(4)) HAD AN INEFFECTIVE CAM LOCK. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898050 ↗
• MalfunctionMay 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, A GII MIS DCF ALIGN GDE ((B)(4)) HAD A BENT PIN, AND A GII MIS DCF ALIGN GDE ((B)(4)) HAD AN INEFFECTIVE CAM LOCK. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897934 ↗
• MalfunctionMay 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION PROCESS, IT WAS FOUND THAT THE BLOCK OF THE GII MIS DCF ALIGN GDE WAS NOT LONGER LOCKING. 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 11881809 ↗
• MalfunctionMay 20, 2021Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII MIS DCF ALIGN GDE NO LONGER TIGHTLY HOLDS THE DISTAL FEMORAL CUTTER. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860146 ↗
• MalfunctionMay 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING INSPECTION OR SET UP BEFORE A TKA SURGERY, IT WAS NOTICED THAT THE GII MIS DCF ALIGN GDE WAS NOT LATCHING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853520 ↗

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