GENESIS II 71430442Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010001375), received between Jul 14, 2019 and Sep 9, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A SMALL PLASTIC PIECE OF ONE (1) GII CR DEEP FLEX ISR TR S1-2 9 CHIPPED OFF. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, NOR IF IT CAUSED ANY DELAY; HOWEVER, NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169883 ↗
• MalfunctionSep 7, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA, A PIECE OF A GENESIS II CR DEEP FLEXION INSERT TRIAL SIZE 1-2 9MM CHIPPED OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374778 ↗
• MalfunctionJul 22, 2022Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GROOVES ON THE BOTTOM OF THE GII CR DEEP FLEX ISR TR S1-2 9 WERE NOTICED TO BE SNAPPED OFF. THIS WAS NOTICED WHEN THE DEVICE WAS HANDLED 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 15090041 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GENESIS II CR DEEP FLEX ISR TR S129 INSERT HAS CRACKED WHILE IT WAS BEING INSERTED. NO INJURIES OR SURGICAL DELAYS WERE REPORTED. AN S AND N BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918637 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE BROKE WHILE TRIALING. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318645 ↗
• MalfunctionOct 1, 2019Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL BROKE DURING USE. S&N BACKUP WAS AVAILABLE. ALL PIECES RECOVERED. NO DELAY TO THE PROCEDURE, NO INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED. NO CLOSURE LETTER NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142436 ↗
• MalfunctionJul 14, 2019Break; Break

  IT WAS REPORTED THAT THAT THE INSERT TRIAL BROKE WHILE REMOVING TRIALS FROM KNEE DURING TKA. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787538 ↗