GENESIS II 71430901Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010481368), received between Dec 16, 2020 and Dec 13, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII PST STB ART TRL 1 2 9MM OF INSERT CRACKED OFF DURING TRIAL EXTRACTION. PIECE WAS LOCATED AND REMOVED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988198 ↗
• MalfunctionApr 11, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, THE GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 1-2 9MM BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646711 ↗
• MalfunctionDec 16, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE GII PST STB ART TRL 1-2 9MM IS PRESENTING WEAR AND TEAR. IT HAS CHIPS AND CRACKS. NO CASE RELATED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11017061 ↗