ATTUNE 1517-10-318Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295055747), received between Aug 1, 2023 and May 20, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER KNEE REVISED ON (B)(6) 2025. A NON-DEPUYSYNTHES TOTAL KNEE WAS EXPLANTED AND AN ATTUNE REVISION CONSTRUCT WAS IMPLANTED. THE PATIENT RECENTLY CAME IN FOR A FOLLOW UP VISIT AND HER WOUND WAS NOT COMPLETELY HEALED AND HAS DRAINAGE. IT WAS DETERMINED TO DO A THOROUGH I&D AND EXCHANGE HER KNEE INSERT; ALL OF THE OTHER COMPONENTS WERE LEFT IN SITU. NO ADVERSE EVENTS TO REPORT IN REGARD TO THE DEPUYSYNTHES PRODUCTS, NO SURGICAL DELAY TO REPORT. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 22055368 ↗
• 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: (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 18139716 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17433811 ↗