ATTUNE 1549-03-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295383017), received between Mar 6, 2023 and Nov 15, 2023 — 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 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR NAUSEA AND VOMITING AND RE-ADMITTED TO HOSPITAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT:(B)(6) 2005 DATE OF REVISION #1: (B)(6) 2022 DATE OF REVISION #2: (B)(6) 2023 DATE OF EVENT: UNK (B)(6) 2023 (RIGHT KNEE) TREATMENT: MEDICAL WORKUP RESULTING IN DX OF SHOWER EMBOLI AND TREATED WITH ELIQUIS

  Patient problems: Embolism/Embolus; Nausea; Vomiting

  MAUDE report 18138743 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION KNEE ARTHROPLASTY IN (B)(6) 2019. SURGEON REMOVED FEMUR AND SLEEVE AND REPLACED WITH A LARGER SIZE SLEEVE. SURGEON SAID THAT THE PATIENT WAS COMPLAINING OF PAIN. FEMUR AND SLEEVE WERE WELL FIXED AND TOOK TIME TO REMOVE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16487210 ↗