GENESIS II 71430324Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010481412), received between Apr 1, 2019 and Sep 18, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, A PIECE OF ONE (1) GII ART INS SPCR TRL 1-2 13MM BROKE OFF; IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087261 ↗
• MalfunctionSep 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A PIECE OF PLASTIC OF ONE (1) GII ART INS SPCR TRL 1-2 13MM BROKE OFF. 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 23075813 ↗
• MalfunctionMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE BACK EDGE OF ONE (1) GII ART INS SPCR TRL 1-2 13MM WAS CHIPPED OFF. 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 22106578 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR, ONE (1) GII ART INS SPCR TRL 1-2 13MM BROKE DURING ITS REMOVAL. THE PROCEDURE WAS COMPLETED, WITHOUT ANY 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 22054419 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A GII ART INS SPCR TRL 1-2 13MM WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064679 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE OUTSIDE THE PATIENT, SURGEON SLID GII ART INS SPCR TRL 1-2 13MM INTO TRIAL TIBIA AND IT SNAPPED. NO PIECES FELL INSIDE THE PATIENT. PROCEDURE CONTINUED WITH A BACKUP DEVICE, WITHOUT A DELAY OR AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611361 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, A PIECE OF THE GII ART INS SPCR TRL 1-2 13MM BROKE OFF OF AND NO LONGER FUNCTIONS PROPERLY. 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 14290061 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT ONE GII ART INS SPCR TRL 1-2 13MM WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477753 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT A GII ART INS SPCR TRL 1-2 13MM PIECE BROKE OFF. THIS HAPPENED AFTER A CASE, THEREFORE NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315988 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE THE GII ART INS SPCR TRL 1-2 13MM WAS FOUND TO BE BROKEN AND IT WAS MISTAKENLY THROWN AWAY. NO BACK UP AND DELAY APPLICABLE FOR THIS EVENT. NO PATIENT OR USER INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910901 ↗
• MalfunctionAug 17, 2020Break; Break

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION IT WAS FOUND THESE INSERT TRIALS VERY WORN AND CHIPPED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10414385 ↗
• MalfunctionAug 15, 2020Break; Break

  IT WAS REPORTED THAT THE GENESIS II ART INSERT SPCR TRIAL 1-2 13MM WAS FOUND BROKEN IN HALF AFTER WASHED IN THE WASHER STERILIZER IN SPD DURING INSPECTION AND RESETTING OF CONSIGNMENT TRAYS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10411804 ↗
• MalfunctionDec 16, 2019Break; Break

  IT WAS REPORTED THAT WHILE IN SURGERY THE INSTRUMENT BROKE DURING THE REMOVAL FROM THE PATIENT. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO SUBSTANTIAL PROCEDURAL DELAY DUE TO THE BREAKAGE OF THE INSTRUMENT. S+N BACK UP WAS AVAILABLE IF NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475463 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SPACER BROKE WHEN IT WAS BEING SNAPPED TO THE OTHER INSTRUMENT. NO DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE. THE DEVICE BROKE OVER THE PATIENT´S INCISION BUT ALL THE PIECES WERE RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9068737 ↗
• MalfunctionJun 16, 2019Break; Break

  IT WAS REPORTED THAT DURING TKA THE DEVICES BROKE. ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. THE BACKUP WAS NOT NEEDED BECAUSE IT WAS AFTER THE TRIAL WAS COMPLETED THAT THE DOCTOR WAS AWARE OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8702576 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSTRUMENT BROKE. NO DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE. PIECE FALL INSIDE THE PATIENT AND WAS RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8468289 ↗