GENESIS II 71430880Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010481320), received between Nov 20, 2019 and Jul 18, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, A GII C/R ART TRL 1-2 9MM BROKE. 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 15038587 ↗
• InjuryNov 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A SMALL FRAGMENT OF A GII C/R ART TRL 1-2 9MM HAD BROKEN OFF. INSTRUMENTS WERE INSIDE THE PATIENT. ALSO, IT LOOKED LIKE WEAR AND TEAR DAMAGE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779224 ↗
• MalfunctionJul 1, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION BEFORE A TKA SURGERY, A GII C/R ART TRL 1-2 9MM WAS CHIPPED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104351 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT DURING A RDG PROCEDURE A FRAGMENT OF THE GII C/R ART TRL 1-2 9MM HAS COME LOOSE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610564 ↗
• MalfunctionNov 20, 2019Break; Break

  IT WAS REPORTED THAT NEAR THE END OF A TKA PROCEDURE WHEN THE POLY TRIAL WAS BEING USED WHILE THE FEMORAL AND TIBIAL COMPONENT WERE BEING CEMENTED IN, AFTER THE CEMENT HARDENED, THE DOCTOR REMOVED THE POLY TRIAL FROM THE KNEE, AND A SMALL CHUNK OF PLASTIC ON THE BOTTOM OF THE POLY TRIAL CHIPPED OFF. THE CHIPPED PLASTIC WAS EASILY RECOVERED FROM THE WOUND. ANOTHER POLY TRIAL WAS NOT REQUIRED, SINCE THE POLY WAS THEN IMPLANTED. THERE WERE NO DELAYS AND NO IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350122 ↗