GENESIS II 71440373Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556034965), received between Dec 20, 2019 and Oct 3, 2024 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Positioning Failure; Material Fragmentation; Deformation Due to Compressive Stress; Positioning Failure; Material Fragmentation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) BOX CHISEL WAS DAMAGED AND WOULD NOT FIT INTO THE CORRESPONDING INSTRUMENT TO CREATE A BOX IN THE FEMUR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 20358704 ↗
• MalfunctionSep 20, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TKA SURGERY, METAL IN A BOX CHISEL WAS CHIPPED SO IT GETS STUCK IN A JRN II BCS BOX PREP GD SZ3-5. 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 17785296 ↗
• MalfunctionDec 22, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA, ONE BOX CHISEL WAS DAMAGED. INSPECTION SHOWED THERE WAS NO MATERIAL FROM THE INSTRUMENT IN THE PATIENT. SURGERY WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, HOWEVER IT REMAINS UNKNOWN HOW. NO OTHER COMPLICATIONS WERE REPORTED. PHOTO OF DEVICE PROVIDED SHOWS DEVICE IS FRACTURED IN THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038161 ↗
• MalfunctionDec 1, 2022Degraded; Flaked; Degraded; Flaked

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THREE (3) BOX CHISELS WERE WORN AND LEAVING METAL SHAVINGS BEHIND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. AT THIS TIME, IT HAS NOT BEEN CONFIRMED IF THE METAL PIECES FELL INTO THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895562 ↗
• MalfunctionNov 28, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, A BOX CHISEL WAS WORN AND LEAVING METAL SHAVINGS BEHIND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868508 ↗
• MalfunctionSep 28, 2022Degraded; Flaked; Degraded; Flaked

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THREE (3) BOX CHISEL WERE WORN AND LEAVING METAL SHAVINGS BEHIND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498753 ↗
• MalfunctionJul 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BOX CHISEL HAS CHIPS OUT OF REAMING EDGE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940643 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT, THE BOX CHISEL 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 14462453 ↗
• MalfunctionNov 16, 2021Failure to Align; Naturally Worn; Failure to Align; Naturally Worn

  IT WAS REPORTED THAT, A BOX CHISEL WAS KNICKED AND NO LONGER FITTING WELL. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 12824024 ↗
• MalfunctionJul 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A BOX CHISEL WAS BROKE. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155462 ↗
• InjuryMay 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A TKA, A BOX CHISEL WAS BENT ON THE END, THIS CAUSED THAT EXTRA REMOVAL OF BONE WAS REQUIRED OUTSIDE OF THE NORMAL CHISELING FROM THE BOX CHISEL IMPACTION. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH THE SAME DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864512 ↗
• MalfunctionMay 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE BOX CHISEL ((B)(4)) DID NOT FIT THROUGH THE LGN HOUSING RESECT COLLET S3-8 ((B)(4)). DEVICES 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 11864010 ↗
• 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 11593352 ↗
• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, THE BOX CHISEL DID NOT FUNCTION PROPERLY DUE TO IS BROKEN. PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY 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 11541412 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION, BOX CHISEL WAS NOTICED TO BE CHIPPED AT THE END FROM MULTIPLE USES. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391235 ↗
• InjuryFeb 22, 2021Material Fragmentation; Dull, Blunt; Material Fragmentation; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA PROCEDURE THREE BOX CHISELS WERE FOUND DULL. METAL SHAVINGS WERE DISCOVERED TO HAVE FALLEN INTO THE PATIENT. SUCTION WAS USED TO RETRIEVE THE METAL SHAVINGS. THE CASE WAS FINISHED USING INSTRUMENTS BUT THEY ARE BADLY WORN AND NOT USABLE ANYMORE. A DELAY OF LESS THAN 30 MIN WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363650 ↗
• InjuryFeb 22, 2021Material Fragmentation; Dull, Blunt; Material Fragmentation; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA PROCEDURE THREE BOX CHISELS WERE FOUND DULL. METAL SHAVINGS WERE DISCOVERED TO HAVE FALLEN INTO THE PATIENT. SUCTION WAS USED TO RETRIEVE THE METAL SHAVINGS. THE CASE WAS FINISHED USING INSTRUMENTS BUT THEY ARE BADLY WORN AND NOT USABLE ANYMORE. A DELAY OF LESS THAN 30 MIN WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363421 ↗
• InjuryFeb 22, 2021Material Fragmentation; Dull, Blunt; Material Fragmentation; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA PROCEDURE THREE BOX CHISELS WERE FOUND DULL. METAL SHAVINGS WERE DISCOVERED TO HAVE FALLEN INTO THE PATIENT. SUCTION WAS USED TO RETRIEVE THE METAL SHAVINGS. THE CASE WAS FINISHED USING INSTRUMENTS BUT THEY ARE BADLY WORN AND NOT USABLE ANYMORE. A DELAY OF LESS THAN 30 MIN WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362985 ↗
• InjuryJan 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHEN PERFORMING THE SECOND BOX CHISEL CUT, THE BOX CHISEL GOT STUCK IN THE GUIDE. IT IS STRUCK. THIS HAPPENED INSIDE THE PATIENT, AND A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED. THERE WAS NO DELAY AND NO HARM TO THE PATIENT. NO OTHER COMPLICATIONS WERE 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

  MAUDE report 11242862 ↗
• MalfunctionDec 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, PRIOR TO SURGERY, BOX CHISEL WAS NOTICED TO BE JAGGED ON THE WORKING END. A BACK-UP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938329 ↗
• InjuryJul 12, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE BOX CHISEL END CHIPPED DURING USE IN CASE. IT WAS INSIDE THE PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10262226 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT DURING TKA BOX CHISEL IS BENT AND IT WOULD NOT FIT THROUGH THE HOUSING COLLET. DELAY GREATER THAN 30 MINUTES REPORTED, BACK-UP DEVICE AVAILABLE AND NO INJURIES HAVE BEEN CONFIRMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9504283 ↗

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