ATTUNE 1511-01-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295436546), received between Jul 8, 2025 and Nov 5, 2025 — classified as 2 injuries.

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

• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE INFECTED. THE SPACER AND ALL CEMENT ARE REMOVED. A THOROUGH I&D IS PERFORMED AND A NEW SPACER IS FASHIONED UTILIZING LPS COMPONENTS. NO PATIENT HARM NOR DELAY WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23477232 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO DRAIN AFTER HER PROCEDURE. LABS LOOK GOOD AND ASPIRATION IS NEGATIVE FOR INFECTION. SURGEON BELIEVES THE ANTIBIOTICS PLACED A THE TIME OF SURGERY ARE CAUSING THE DRAINAGE, SO HE CHOSE TO REMOVE ALL COMPONENTS AND PLACE NEW ONES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THEY WERE FUNCTIONING AS EXPECTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22441325 ↗