GENESIS II 71430454Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010481344), received between Apr 28, 2020 and Sep 23, 2025 — classified as 4 malfunctions.

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

• MalfunctionSep 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE OF THE PLASTIC OF ONE (1) GII DSH ART TRL 1-2 9MM BROKE DURING USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23120293 ↗
• MalfunctionFeb 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT A SMALL PIECE OF A GENESIS II DISHED ARTICULAR TRIAL SIZE 1-2 9MM SEEMS TO HAVE BROKEN OFF. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543128 ↗
• MalfunctionSep 4, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TRIAL WAS BROKE OUTSIDE THE PATIENT AND ALL PIECE WERE RECOVERED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS 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 10496893 ↗
• MalfunctionApr 28, 2020Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL WAS BROKEN DURING A CASE. THE DEVICE DID NOT BREAK INSIDE THE PATIENT'S WOUND. ADDITIONALLY, NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING AN S&N BACKUP DEVICE. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10004780 ↗