ATTUNE AFFIXIUM 1506-21-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295507482), received between Jun 5, 2023 and Sep 11, 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.

• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SINGLE STAGE REVISION FOR AN ACUTE INFECTION. ATTUNE IMPLANTS WERE REMOVED, WOUND I&D, AND NEW ATTUNE IMPLANTS WERE USED. IMPLANTS ARE UNAVAILABLE FOR RETURN AND THERE WAS NO DELAY IN THE PROCEDURE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17724359 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED):

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 17066990 ↗