ATTUNE 1520-20-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295542360), received between Dec 22, 2025 and May 27, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH PERSISTENT PAIN AND POOR ROM POST TKA BY AN OUTSIDE SURGEON AND POLY AND PATELLA EXCHANGE ON (B)(6) 2023 BY THE TREATING SURGEON. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED. PATIENT BELIEVES SHE HAS AN ALLERGY TO NICKEL AND WELL-FIXED FEMUR, POLY AND TIBIA WERE REMOVED AND THE COMPONENTS WERE REVISED TO A COMPANY OFFERING NICKEL FREE ALTERNATIVE PROSTHESES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. PATELLA COMPONENT WAS LEFT IN PLACE FROM 3-16-23 AS IT WAS WELL FIXED AND TRACKS WELL. NO LOT INFORMATION WAS AVAILABLE IN OPTIMIZE AS THIS INFORMATION WAS NOT TRANSFERRED IN THE MIGRATION FROM COMPASS TO OPTIMIZE. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25304313 ↗
• InjuryFeb 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED FOLLOWING A SECOND REVISION SURGERY THAT THE ATUNE CR RT MS INS SZ 4 10 WAS INVOLVED IN THE DISLODGEMENT OF THE MS INSERT DURING FLEXION, WITH THE INSERT FOUND ANTERIOR TO THE PATELLA AND EASILY REMOVED MANUALLY. THE REVISION SURGERY WAS PERFORMED TO REPLACE THE 10MM INSERT WITH AN 8MM INSERT DUE TO PERSISTENT MEDIOLATERAL TIGHTNESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 24323404 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE: LEFT KNEE

  Patient problems: Pain

  MAUDE report 24233362 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED JOINT AND THE DOCTORS DID A WASHOUT AND A POLY SWAP. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23865027 ↗