ATTUNE 1517-10-618Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295056072), received between Aug 12, 2019 and Apr 23, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A INFECTED KNEE SO DOCTOR OPTED TO WASH OUT THE KNEE AND DO A POLY SWAP. THIS WAS THE ONLY INFORMATION THAT WAS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24966795 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO JOINT INFECTION. SURGEON PERFORMED AN I&D POLY SWAP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21945582 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) POLY SWAP POSSIBLE INFECTION. UNABLE TO DETERMINE INFECTION. THERE WAS NO DELAY IN SURGERY. NO ADVERSE EFFECTS REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20225759 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION WAS COMPLETED DUE TO CELLULITIS. POLY WAS EXCHANGED. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN DOR:(B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Cellulitis

  MAUDE report 19654581 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2023; SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16994555 ↗
• InjuryFeb 1, 2022Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT FELL, KNEE WAS ¿BUCKLED¿ AND DISLOCATED. CLOSED REDUCTION WAS ATTEMPTED BUT WAS UNSUCCESSFUL. OPEN I&D WITH POLY EXCHANGE WAS PERFORMED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 13415639 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SOFT TISSUE ISSUES. A POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11711927 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AFFECTED SIDE IS THE RIGHT KNEE. PREVIOUS FUNGAL INFECTION OF PRIMARY TKR, REVISED IN 2 STAGES TO ATTUNE REVISION ONCE FUNGAL INFECTION WAS CLEARED. PRESENTED BACK FOR SUBSEQUENT REVISION WITH BACTERIAL INFECTION. THE ORIGINAL REVISION WAS OF A WRIGHT MEDICAL KNEE, DEFINITELY NOT A DEPUY PRODUCT, SO NO REPORT WAS COMPLETED FOR THE FIRST REVISION FOR THE PRIMARY PRODUCT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8883937 ↗