ATTUNE 1517-11-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295056508), received between Nov 22, 2021 and Nov 22, 2021 — 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 18, 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.

• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF HAVING HIGH FEVERS OVER THE LAST FEW DAYS, HE WAS ADMITTED TO HOSPITAL IN (B)(6) AND TRANSFERRED TO (B)(6) HOSPITAL WITH AN INFECTED LEFT ATTUNE REVISION KNEE REPLACEMENT. LEFT KNEE WAS REVISED ON (B)(6) 2021 AT (B)(6) HOSPITAL POSSIBLY DONE IN THE PRIVATE HOSPITAL. UNSURE OF WHO THE SURGEON WAS AT THE TIME. PATIENT HAD LEFT KNEE DEBRIDED AND WASHED OUT WITH TISSUE AND FLUID SAMPLES TAKEN. POLYETHYLENE INSERT WAS EXCHANGED FOR ONE THE SAME SIZE ALSO. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 12852555 ↗