ATTUNE 1504-11-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295042129), received between Mar 15, 2023 and Feb 12, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21364231 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. DOCTOR DECIDED TO DO A REVISION OF PRIMARY TKA. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19950425 ↗
• InjuryJul 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO FEMORAL IMPLANT LOOSENING. THE NON-ARTICULAR SURFACE OF THE PRESS FIT (CEMENTLESS) CC FEMORAL COMPONENT SHOWS NO RELATIVE MOTION, SPARSE BONE WITH EXCELLENT INTERDIGITATION. AT REVISION THE TIBIAL INSERT HAD CRACKING AROUND THE RIM.

  Patient problems: Insufficient Information

  MAUDE report 19837145 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED TIBIAL PAIN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 17754892 ↗
• InjuryMar 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING AT UNKNOWN INTERFACE. TIBIA HAD ALREADY BEEN REVISED ON (B)(6) 2022. FEMUR WAS REVISED AND CONVERTED TO A CRS FEMUR WITH A CEMENTED STEM. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16545302 ↗