GENESIS II 71440890Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 03596010476074), received between Feb 5, 2019 and May 28, 2026 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (28 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII OXINIUM FEMORAL IMPACTOR WAS BROKEN AT THE FIRST SCREW THREAD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25312402 ↗
• MalfunctionMay 5, 2026Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII OXINIUM FEMORAL IMPACTOR BROKE DURING FEMORAL IMPLANTATION. NOTHING FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089359 ↗
• MalfunctionSep 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT, AFTER A FEW HITS WITH THE MALLET, THE NECK OF ONE (1) GII OXINIUM FEMORAL IMPACTOR BROKE. THE REMAINING HALF OF THE IMPACTOR WAS DISENGAGED FROM THE IMPLANT AND THE COMPONENT WAS FINISHED OFF WITH A SECONDARY IMPACTOR. NONE OF THE PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151770 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII OXINIUM FEMORAL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY. HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700258 ↗
• MalfunctionDec 3, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, DOCTOR WAS HAMMERING ON A GII OXINIUM FEMORAL IMPACTOR AND IT BROKE. 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 20833297 ↗
• MalfunctionNov 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TOP OF A GII OXINIUM FEMORAL IMPACTOR BROKE OFF EXTERNAL FROM PATIENT, NO PIECES FELL INTO PATIENT. 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 20772775 ↗
• MalfunctionSep 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING IMPACTION IN A TKA SURGERY, ONE (1) GII OXINIUM FEMORAL IMPACTOR BROKE INTO TWO PARTS. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186659 ↗
• MalfunctionAug 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FEMORAL ATTACHMENT OF A GII OXINIUM FEMORAL IMPACTOR BROKE OFF WHILE PERFORMING HANDLING ACTIVITIES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633312 ↗
• MalfunctionJun 19, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING A TKA SURGERY. A GII OXINIUM FEMORAL IMPACTOR BROKE DURING IMPACTION. IT IS UNKNOWN, HOW SURGERY WAS COMPLETED OR IF A DELAY OCCURRED, DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159985 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A GII OXINIUM FEMORAL IMPACTOR WAS FRACTURED AFTER FEMUR WAS IMPACTED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. 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 15875766 ↗
• MalfunctionOct 26, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE LOCK PIN OR SCREW OF ONE (1) GII OXINIUM FEMORAL IMPACTOR WAS LOOSE AND BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674914 ↗
• MalfunctionJul 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE GII OXINIUM FEMORAL IMPACTOR BLACK BUMPER WAS LOOSE AND MOVES WHEN IMPLANT IS ON. THE IMPACTOR NO LONGER FUNCTIONS PROPERLY. AS THIS WAS NOTICED DURING SET UP FOR SURGERY, THE PATIENT WAS NOT YET INVOLVED. NO DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15056964 ↗
• MalfunctionMay 27, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A GII OXINIUM FEMORAL IMPACTOR UPON IMPACTING THE FEMUR IMPLANT THE IMPACTOR BROKE IN HALF. DEVICE INSIDE 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 14520251 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII OXINIUM FEMORAL IMPACTOR BROKE DURING IMPACTION. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432368 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II OXINIUM FEMORAL IMPACTOR WAS NOTICED TO BE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592015 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT A GII OXINIUM FEMORAL IMPACTOR BROKE IN HALF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282122 ↗
• InjuryDec 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII OXINIUM FEMORAL IMPACTOR BROKE INSIDE PATIENT. PIECES DID NOT FALL INTO THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY AS CONSEQUENCE OF THE ALLEGATION. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014240 ↗
• InjuryNov 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A GII OXINIUM FEMORAL IMPACTOR BROKE WHILE IMPACTING. NO SUBSTANTIAL PROCEDURAL DELAY BECAUSE A FUNCTIONING, SMITH & NEPHEW BACK UP DEVICE WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE. NO HARM TO PATIENT OR STAFF. PIECES WERE SUCCESSFULLY RETRIEVED. NO SUPPLEMENTAL PATIENT INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771392 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, WHILE IMPACTING A FEMORAL COMPONENT THE GII OXINIUM FEMORAL IMPACTOR BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY 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 12771157 ↗
• MalfunctionOct 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE GII OXINIUM FEMORAL IMPACTOR BROKE. INCIDENT OCCURRED EXTERNAL THE PATIENT AND NO PIECES FELL INSIDE THE INCISION. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677327 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II OXINIUM FEMORAL IMPACTOR BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY 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 12233512 ↗
• MalfunctionJul 1, 2021Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT DURING INSPECTION OF THE GII OXINIUM FEMORAL IMPACTOR HAD A DAMAGE CAUSING IT NOT TO FUNCTION PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105159 ↗
• MalfunctionMay 21, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA, IT WAS NOTICED THAT A GENESIS II OXINIUM FEMORAL IMPACTOR WON'T LOOSEN UP. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH AN AVAILABLE SMITH AND NEPHEW BACK UP DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864473 ↗
• MalfunctionApr 22, 2021Break; Break

  IT WAS REPORTED THAT A GENESIS II OXINIUM FEMORAL IMPACTOR IS BROKEN, IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711138 ↗
• InjuryMar 3, 2021Break; Break

  IT WAS REPORTED THAT, A GENESIS II OXINIUM FEMORAL IMPACTOR BROKE. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS INSIDE THE PATIENT. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. NO PATIENT INFORMATION NEITHER OPERATIVE REPORTS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116