ATTUNE 1504-40-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295042228), received between Dec 6, 2019 and May 15, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN DOING WELL AND PRESENTED IN AN OUTSIDE FACILITY WITH SUSPECTED INFECTION WHILE ON VACATION. A WOUND VAC WAS PLACED AND PATIENT RETURNED TO HIS TREATING SURGEON FOR CARE. ALL COMPONENTS WERE WELL FUNCTIONING AND WELL FIXED SO NO ALLEGATION WAS MADE AGAINST THE COMPONENTS. THERE WAS NO DELAY NOR PATIENT HARM WAS NOTED. A STATIC APACER WAS FASHIONED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTIC CEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THIS PATIENT HAS HAD INTERVENTIONS ON THE FOLLOWING DATES WHERE IMPLANTS WERE EXCHANGED AND DERS WERE SUBMITTED. (B)(6) 2025 (B)(6), (B)(6) 2025 (B)(6). CEMENT UTILIZED WAS DEPUY 2 WITH GENT AND HOSPITAL OWNED. HIS PATELLAR COMPONENT HAD BEEN PLACED ON (B)(6) 2022 AND RETAINED FROM HIS PRIMARY TKA. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE. (B)(4) WERE CREATED FOR THE FIRST AND SECOND REVISION". ALL IMPACTED PRODUCTS IN THESE TWO PC'S ARE PART OF THE SAME THIRD REVISION SURGERY FOR ONGOING INFECTION--IN THIS THIRD REVISION ALL PRODUCTS WERE REMOVED, AND AN ANTIBIOTIC SPACER WAS IMPLANTED." THE KNEE (WITH ALL OF THE CURRENT IMPACTED PRODUCTS EXCEPT THE INSERT) WAS DISCOVERED TO

  Patient problems: Unspecified Infection

  MAUDE report 25189658 ↗
• InjuryDec 6, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  THE PATIENT WAS REVISED DUE TO PATELLA MALTRACKING. THE DOCTOR DIDN'T PUT ENOUGH EXTERNAL ROTATION ON THE FEMUR DURING THE REVISION AND ARE GOING BACK IN TO CORRECT THIS PROBLEM SO THE PATELLA TRACKS BETTER. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9429527 ↗