ATTUNE 1518-20-305Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295541486), received between Aug 22, 2023 and Dec 4, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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.

• MalfunctionDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THE MS LINER WAS DAMAGED UPON INSERTION; ANOTHER ONE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715284 ↗
• MalfunctionAug 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT A TKA FOR OA ON LEFT KNEE. IN THE SURGERY, THE LINER COULD NOT BE INSERTED. AS FAR AS THE SALES REP COULD SEE, THERE WAS NO PROBLEM WITH THE USAGE, AND IT APPEARED THAT THERE WAS A PROBLEM WITH THE INSERT. THE SAME SIZE LONG-TERM UNIT WAS USED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840033 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR TITANIUM ALLERGY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17594835 ↗