GENESIS II 71430903Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010481375), received between Aug 19, 2020 and Jul 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII PST STB ART TRL 1-2 11MM WAS CHIPPED. THIS HAPPENED BEFORE USE IN PATIENT. 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 12103819 ↗
• MalfunctionAug 19, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THAT THE TRIAL WAS CHIPPED, OUTSIDE THE PATIENT. NOT ANY PIECE FELL INTO THE PATIENT AND ALL PIECES WERE RECOVERED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND BACKUP FROM SMITH&NEPHEW WAS AVAILABLE TO FINISH THE SURGERY. NO PATIENT INJURY OR OTHER COMPLICATION WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10426784 ↗