GENESIS II 71440198Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010214416), received between Feb 28, 2021 and Jul 1, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE ARTICULAR SURFACE FIXING PIN OF ONE (1) GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD BROKE WHEN REMOVED AFTER IMPACTING THE GUIDE, CAUSING THE EXTRAMEDULLARY GUIDE TO NOT BE PROPERLY FIXED. NO PIECE FELL INTO THE WOUND. NO FURTHER INTERVENTION WAS REQUIRED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379114 ↗
• MalfunctionMay 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE OF THE FIXATION TEETH OF A GII TIB ALIGN SPIKED FIX ROD BROKE OFF DURING THE TIBIAL CUT. A PIECE WAS RETRIEVED FROM THE PATIENT; HOWEVER, IT IS UNKNOWN HOW. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO HARM WAS CAUSED TO THE PATIENT AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270456 ↗
• MalfunctionApr 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE LONGER FIXATION SPIKE OF A GII TIB ALIGN SPIKED FIX ROD WAS NOTICED TO BE NOT SHARP, AFTER IT WAS USED. IT LOOKED LIKE THE TIP HAD BROKEN OFF, THOUGH IS A SMOOTH. AN X-RAY WAS PERFORMED IMMEDIATELY POST OP TO CHECK FOR ANY METAL DEBRIS, AND NO SIGN OF METAL WORK WAS SEEN. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164782 ↗
• MalfunctionDec 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE OF THE SPIKES OF A GII TIB ALIGN SPIKED FIX ROD BROKE. IT WAS REALIZED AFTER CUT WAS MADE. PIECES FELL INTO THE WOUND AND WERE RETRIEVED BY HAND. NO INJURY OR SURGICAL DELAY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357206 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED THAT, THE SPIKE OF A GII TIB ALIGN SPIKED FIX ROD IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396390 ↗
• 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 12487893 ↗
• MalfunctionSep 1, 2021Break; Break

  IT WAS REPORTED THAT THE MAIN SPIKE OF A JOURNEY EM PROXIMAL FIXATION BRIDGE WAS MISSING. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT (BEFORE SURGERY), THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408138 ↗
• MalfunctionJun 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE PIN OF A GII TIB ALIGN SPIKED FIX ROD DETACHED. DEVICE 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 12000525 ↗
• MalfunctionMay 13, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, IT WAS NOTICED THAT THE TIP OF THE LONGER SPIKE ON THE GENESIS II TIB ALIGN SPIKED FIX ROD WAS WORN AND BROKEN. 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 11820637 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP ((B)(4)) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD ((B)(4)), THE SCREWDRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT ((B)(4)), R3 0 DEG 32 MM TRIAL 48 MM ((B)(4)), THE HONEYCOMB ((B)(4)), THE BOX CHISEL ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT ((B)(4)), THE LAG SCREW 3.2 GUIDE PIN SLEEVE ((B)(4)), THE MEDIUM HEXDRIVER ((B)(4)), THE SUBTROC LAG SCREW DRIVER ((B)(4)), THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) TWO THIN OSTEO BLADE 8X3 ((B)(4)), THE THIN OSTEO BLADE 12X3 ((B)(4)) AND THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) WERE NOTICED CRACKED. THE NAIL PROX DROP ((B)(4)), THE META ANTERIOR DROP ((B)(4)), THE MI Z HANDLE ACET REAMER ((B)(4)) AND TWO THIN OSTEO BLADE 8X3 ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593371 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP ((B)(4)) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD ((B)(4)), THE SCREWDRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT ((B)(4)), R3 0 DEG 32 MM TRIAL 48 MM ((B)(4)), THE HONEYCOMB ((B)(4)), THE BOX CHISEL ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT ((B)(4)), THE LAG SCREW 3.2 GUIDE PIN SLEEVE ((B)(4)), THE MEDIUM HEXDRIVER ((B)(4)), THE SUBTROC LAG SCREW DRIVER ((B)(4)), THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) TWO THIN OSTEO BLADE 8X3 ((B)(4)), THE THIN OSTEO BLADE 12X3 ((B)(4)) AND THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) WERE NOTICED CRACKED. THE NAIL PROX DROP ((B)(4)), THE META ANTERIOR DROP ((B)(4)), THE MI Z HANDLE ACET REAMER ((B)(4)) AND TWO THIN OSTEO BLADE 8X3 ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593370 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP (B)(4) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD (B)(4), THE SCREWDRIVER RELEASE HANDLE (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT (B)(4), R3 0 DEG 32 MM TRIAL 48 MM (B)(4), THE HONEYCOMB (B)(4), THE BOX CHISEL (B)(4), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT (B)(4), THE LAG SCREW 3.2 GUIDE PIN SLEEVE (B)(4), THE MEDIUM HEXDRIVER (B)(4), THE SUBTROC LAG SCREW DRIVER (B)(4), THE ACCORD DUAL ENDED HEX DRIVER (B)(4) TWO THIN OSTEO BLADE 8X3 (B)(4), THE THIN OSTEO BLADE 12X3 (B)(4) AND THE JOURNEY DCF AP FEM CUT BLK 4 (B)(4) WERE NOTICED CRACKED. THE NAIL PROX DROP (B)(4), THE META ANTERIOR DROP (B)(4), THE MI Z HANDLE ACET REAMER (B)(4) AND TWO THIN OSTEO BLADE 8X3 (B)(4) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593362 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP ((B)(4)) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD ((B)(4)), THE SCREWDRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT ((B)(4)), R3 0 DEG 32 MM TRIAL 48 MM ((B)(4)), THE HONEYCOMB ((B)(4)), THE BOX CHISEL ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT ((B)(4)), THE LAG SCREW 3.2 GUIDE PIN SLEEVE ((B)(4)), THE MEDIUM HEXDRIVER ((B)(4)), THE SUBTROC LAG SCREW DRIVER ((B)(4)), THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) TWO THIN OSTEO BLADE 8X3 ((B)(4)), THE THIN OSTEO BLADE 12X3 ((B)(4)) AND THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) WERE NOTICED CRACKED. THE NAIL PROX DROP ((B)(4)), THE META ANTERIOR DROP ((B)(4)), THE MI Z HANDLE ACET REAMER ((B)(4)) AND TWO THIN OSTEO BLADE 8X3 ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593356 ↗
• MalfunctionMar 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA THE TIP OF ONE OF A GENESIS II TIB ALIGN SPIKED FIX ROD WAS BROKEN. THE SURGEON MADE THE TIBIAL CUT WITH THE SPIKED ROD IN SITU TO GIVE THE TIBIAL CUTTING BLOCK MORE STABILITY. EVEN THOUGH THIS WAS REPORTED AFTER SURGERY; ACCORDING TO THE DESCRIPTION THERE WAS PATIENT WAS INVOLVEMENT. THERE WAS NO DELAYS AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478617 ↗
• MalfunctionFeb 28, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA, WAS NOTICED THAT THE GII TIB ALIGN SPIKED FIX ROD WAS DAMAGED. ONE OF THE SPIKES HAS BROKEN OFF THE ROD. THE SCRUB NURSE SUGGESTED THE SAWBLADE MAY HAVE COME INTO CONTACT WITH IT WHEN THE SURGEON WAS MAKING THE TIBIAL CUT, AS HE LEAVES THE SPIKED ROD IN PLACE TO GIVE ADDITIONAL STABILITY TO THE CUTTING BLOCK. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE WITH NO SURGICAL DELAY AND NO INJURIES TO THE PATIENT. 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 11390979 ↗

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