ATTUNE 1511-01-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295419617), received between Apr 22, 2025 and May 15, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 4 most recent of 4 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 BE

  Patient problems: Unspecified Infection

  MAUDE report 25188228 ↗
• InjuryMay 14, 2026Osseointegration Problem

  IT WAS REPORTED THAT REVISION OF DISTAL FEMUR FOR BROKEN SLEEVE/STEM JUNCTION. IT WAS STATED THAT SLEEVE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25174780 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT IMPLANT REMOVAL DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22730693 ↗
• InjuryApr 22, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON REVISED PATIENT'S DISTAL FEMORAL REPLACEMENT BECAUSE THE ATTUNE 55MM FEMORAL SLEEVE WAS LOOSE. THERE WAS AN ATTUNE REVISION 55MM FULLY POROUS FEMORAL SLEEVE LOOSENING AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21880729 ↗