GENESIS II 71928199Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556045497), received between Oct 2, 2018 and Dec 26, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON THE PATIENT DUE TO INCREASED PAIN AND REDUCED RANGE OF MOTION. NO INSTABILITY IDENTIFIED, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 8197540 ↗
• InjuryOct 2, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE POOR RANGE OF MOTION AND EXPERIENCING MORE PAIN THAN EXPECTED. AN ASPIRATION WAS PERFORMED TO RULE OUT INFECTION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7927720 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT AS SHE DEVELOPED ARTHROFIBROSIS.

  Patient problems: No Code Available

  MAUDE report 7927686 ↗