ATTUNE AOX AFFIXIUM 1518-21-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295523628), received between Jan 5, 2026 and Mar 11, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED; IMPLANTS REMOVED BECAUSE OF INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24570320 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A FALL POST TOTAL KNEE ARTHROPLASTY (TKA), RESULTING IN A TORN SURGICAL REPAIR AND DAMAGE TO THE QUADRICEPS MECHANISM. THE SURGEON DETERMINED THAT SHORTENING THE FEMORAL CONSTRUCT WOULD REDUCE TENSION ON THE REPAIR, LEADING TO REMOVAL OF THE FEMORAL COMPONENTS AND EXCHANGE OF THE PATELLAR COMPONENT TO A CEMENTED VERSION. ALL COMPONENTS WERE FUNCTIONING WELL PRIOR TO THE FALL, AND THERE WAS NO DELAY OR ADDITIONAL PATIENT HARM NOTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24474321 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STAGE 1 KNEE REVISION WAS PERFORMED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23983200 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED KNEE, ALL COMPONENTS REMOVED. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23959738 ↗