ATTUNE 1516-20-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295045304), received between Dec 11, 2019 and Dec 11, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BEEN EXPERIENCING DIFFICULTY WITH STAIRS. UPON EXAMINING, PATIENT FELT HER KNEE WAS SLIGHTLY, BUT GLOBALLY UNSTABLE. SURGEON COMMENTED THAT THIS PATIENT IS HYPERMOBILE IN OTHER JOINTS AS WELL. SURGEON PERFORMED A POLY EXCHANGE, REMOVING A SIZE 2 7MM CR FB INSERT AND INCREASING IT TO A SIZE 2 10MM INSERT. SURGEON WAS SATISFIED WITH THE PATIENT'S STABILITY AFTER MAKING THIS CHANGE. ALSO OF NOTE, A POLY TRIAL WAS BROKEN DURING TRIAL EXTRACTION. ALL PIECES WERE RECOVERED. DOI: (B)(6) 2018. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 9450350 ↗