GENESIS II 71430340Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010481290), received between Sep 3, 2019 and Aug 11, 2022 — classified as 5 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. 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.

• MalfunctionAug 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE GII ART INS SPCR TRL 1-2 18 MM WAS FOUND TO BE BROKEN UPON RETURN TO THE WAREHOUSE. AS THIS WAS NOTICED AFTER PROCEDURE, THE PATIENT WAS NO INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211266 ↗
• 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 11967630 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A CONSIGNMENT INSPECTION THE DEVICE WAS FOUND WITH CORROSION/DISCOLORATION. THE DEVICE WILL BE RETURNED. THE INVESTIGATION FOUND THAT THERE WERE LITTLE PIECES BREAKING OFF IN CERTAIN AREAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642880 ↗
• MalfunctionJul 24, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE GII ART INS SPCR TRL 1-2 18MM WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10319499 ↗
• MalfunctionSep 3, 2019Break; Break

  IT WAS REPORTED THAT WHILE REMOVING INSERT THE BLUE PLASTIC CHIPPED AT ONE CORNER. ALL PIECES ACCOUNTED FOR AS PER SURGEON. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8958230 ↗