ATTUNE 1504-40-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295042235), received between Jan 9, 2023 and Apr 8, 2024 — 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 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.

• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY. B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT SIDE. C. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, IT WAS NOT. D. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO THERE WAS NOT. E. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, THEY WERE NOT, THE LAXITY IN FLEXION WAS BELIEVED TO BE SOFT TISSUE RELATED. F. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, I DON¿T BELIEVE SO AS THE FIRST REVISION ONLY USED AN 8MM POLY.

  Patient problems: Joint Laxity

  MAUDE report 19067459 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION SO DOCTOR PULLED ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. (B)(6). AFFECTED SIDE- UNKNOWN KNEE

  Patient problems: Unspecified Infection

  MAUDE report 18335867 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE INSTABILITY AND PAIN IN WHOLE LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: ORAL MEDICATION AND PHYSICAL THERAPY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16124345 ↗