GENESIS II 71430846Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010213594), received between Aug 17, 2020 and Sep 3, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 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 3, 2023Break; Break

  IT WAS REPORTED THAT A GII P/S ART TR SZ7-8 11MM BROKE DURING TRIALING. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675076 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A GII P/S ART TR SZ7-8 11MM HAS SPLIT IN THE MIDDLE. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008852 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT THE STEM ON THE BACK OF A GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 8 11MM BROKE OFF. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934940 ↗
• MalfunctionMar 16, 2022Crack; Crack

  IT WAS REPORTED THAT A GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 8 11MM IS CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778403 ↗
• MalfunctionMar 16, 2022Crack; Crack

  IT WAS REPORTED THAT A GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 8 11MM IS CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778381 ↗
• MalfunctionJun 9, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT 4 CONSTRAINED INSERT TRIALS, 4 ARTICULAR INSERT SPACER TRIALS, 4 POSTERIOR STABILIZED HIGH FLEXION INSET TRIALS AND 3 POSTERIOR STABILIZING ARTICULAR TRIALS FROM GENESIS II SYSTEM ARE BEING RETURNED FOR REPLACEMENT BECAUSE THEY'RE COVERED IN SCRATCHES, CHIPS AND CRACKS. NO CASE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968169 ↗
• 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 10414391 ↗