ATTUNE 1547-06-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295382805), received between Feb 26, 2025 and Nov 24, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 reports).

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.

• InjuryNov 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL KNEE REVISION DONE BY THE DOCTOR AT THE HOSPITAL (B)(6) 2020. FEMUR BECAME LOOSE AND PATIENT WAS BROUGHT IN BY THE HOSPITAL FOR A FEMUR REVISION. FEMORAL COMPONENTS AND RP REVISION INSERT WERE REMOVED. THE RP REVISION TIBIA WAS NOT LOOSE AND STAYED IMPLANTED. NO COMPLICATIONS OR DELAYS IN SURGERY DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23633227 ↗
• InjuryFeb 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO FEMUR BEING LOOSE. THE LOOSENING INTERFACE WAS CEMENT BONE INTERFACE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21472323 ↗
• InjuryFeb 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO FEMUR BEING LOOSE. THE LOOSENING INTERFACE WAS CEMENT BONE INTERFACE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21472322 ↗