GENESIS II 71440190Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 03596010214379), received between Nov 30, 2017 and May 19, 2026 — classified as 19 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Break” (75 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 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, A GII FEMORAL IMPACTOR BROKE OFF AT THE PAD. NO PIECE FELL IN PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224763 ↗
• MalfunctionMay 19, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, A GII FEMORAL IMPACTOR BROKE OFF AT THE PAD. NO PIECE FELL IN PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224756 ↗
• MalfunctionMar 15, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, UPON THE FINAL MALLET STRIKE, THE PLASTIC OF ONE (1) GII FEMORAL IMPACTOR SNAPPED APART. ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601488 ↗
• MalfunctionNov 3, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A TKA, THE BLACK PLASTIC OF A GII FEMORAL IMPACTOR WAS NOTICED TO BE FLAKING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451008 ↗
• MalfunctionSep 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GII FEMORAL IMPACTOR FRACTURED; THE PROCEDURE WAS PERFORMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A S+N BACKUP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087724 ↗
• MalfunctionJun 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE PLASTIC OF ONE (1) GII FEMORAL IMPACTOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY OR INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125120 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII FEMORAL IMPACTOR 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 21749049 ↗
• MalfunctionDec 10, 2024Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE BLACK PAD IN A GII FEMORAL IMPACTOR IS WEARING AWAY AND CHIPPING OFF PIECES. 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 20894267 ↗
• MalfunctionNov 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, PART OF THE GII FEMORAL IMPACTOR BROKE OFF WHEN THE ORIGINAL PROSTHESIS WAS IMPACTED. THE BROKEN PIECE WAS COMPLETELY RECOVERED AND DID NOT END UP IN THE PATIENT. NO PART HAS REMAINED IN THE BODY. 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 20776291 ↗
• MalfunctionNov 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE BLACK HEAD PART OF ONE (1) GII FEMORAL IMPACTOR BROKE OFF WHILE IMPACTING 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 20745615 ↗
• MalfunctionOct 23, 2024Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TKA, SURGEON NOTICED THE GII FEMORAL IMPACTOR WAS DAMAGED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION OF THE GII FEMORAL IMPACTOR HAVE CONCLUDED THAT PARTS OF THE PLASTIC FEMORAL IMPACTOR BUMPER ARE FRACTURED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517942 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII FEMORAL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 20452235 ↗
• MalfunctionJul 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, A CHUNK AT THE END OF THE GII FEMORAL IMPACTOR BROKE OFF THE PAD WHILE IMPACTING THE FEMORAL COMPONENT. NO PIECES FELL INTO PATIENT. THERE WAS NO 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 19794046 ↗
• MalfunctionJun 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, IN A GII FEMORAL IMPACTOR, THE BLACK PLASTIC IS COMING OFF. THE PIECES WERE PICKED OUT OF THE PATIENT. 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 19554525 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII FEMORAL IMPACTOR BROKE WHILE IMPLANTING THE FEMUR. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183452 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE PLASTIC BUMPERS ON THE GII FEMORAL IMPACTOR BROKE. ALL PIECES WERE RECOVERED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021363 ↗
• MalfunctionFeb 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) GII FEMORAL IMPACTOR WAS WORN AND CHIPPED. 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 18670313 ↗
• MalfunctionFeb 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) GII FEMORAL IMPACTOR HAD THE PS PORTION CHIPPED AWAY AND DIDN'T IMPACT AS IT SHOULD. 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 18635114 ↗
• MalfunctionNov 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII FEMORAL IMPACTOR BROKE WHILE THE SURGEON WAS IMPLANTING A FEMORAL COMPONENT, THE HEAD COMPLETELY BROKE OFF; NO PIECE(S) FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18234382 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE TIP OF A GII FEMORAL IMPACTOR BROKE, NO PIECES CAME INTO CONTACT WITH THE PATIENT, AND ALL WERE ACCOUNTED FOR. 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 18035879 ↗
• MalfunctionMay 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY THE BLACK 'BLOCK' PART OF THE GII FEMORAL IMPACTOR WAS FRACTURED IN HALF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989162 ↗
• MalfunctionMay 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE IMPACTOR HEAD OF ONE (1) GII FEMORAL IMPACTOR WAS BROKEN WHILE IMPACTING THE FEMORAL COMPONENT. THE PIECE CRACKED IN HALF ON IMPACTION. NOTHING FELL INTO THE PATIENT. 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 16970548 ↗
• MalfunctionMay 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII FEMORAL IMPACTOR BROKE DURING FINAL IMPACTION. BACK-UP DEVICE WAS AVAILABLE BUT NOT REQUIRED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857716 ↗
• MalfunctionDec 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII FEMORAL IMPACTOR BROKE AT THE PIN/FIXATION AREA. ALL PIECES WERE RECOVERED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921719 ↗
• MalfunctionNov 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE PLASTIC PIECE OF THE GII FEMORAL IMPACTOR BROKE WHEN IMPACTING THE FEMUR. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED 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 15721307 ↗

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