ATTUNE 1518-20-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295541592), received between Aug 14, 2023 and Jan 15, 2026 — 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 16, 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.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DEEMED TO BE UNSTABLE. KNEE WAS REVISED TO CONSTRAINED IMPLANT. THERE WAS NO DELAY AND NO HARM TO PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24083104 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A FALL WHICH DEMISED THE WOUND. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 20291057 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 THE PATIENT HAD A REVISION OF LEFT TOTAL KNEE PREPLACEMENT, OPEN LYSIS OF ADHESIONS, TO ADDRESS ANKYLOSIS, ARTHROFIBROSIS, STIFFNESS, AND PAIN OF THE LEFT KNEE. THE INDICATIONS FOR SURGERY INCLUDED A FAILED PREVIOUS MANIPULATION UNDER ANESTHESIA AND MEDICATIONS AND INJECTIONS. DURING THIS CURRENT PROCEDURE THE POLY WAS REVISED AND SCAR TISSUE WAS REMOVED.

  Patient problems: Adhesion(s); Muscular Rigidity; Osteolysis; Pain

  MAUDE report 17539634 ↗