ATTUNE 1517-10-716Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295056171), received between Feb 5, 2020 and Apr 30, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED DUE TO INFECTION AND WASH OUT. THERE WAS NO HARM DONE TO THE PT. NOR DELAY TO THE CASE. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25042697 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS I&D POLY EXCHANGE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637457 ↗
• InjuryNov 25, 2025Adverse 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. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23643964 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS IMPLANTS IN AS TEMPORARY SPACER DUE TO INFECTED KNEE. THE PATIENT HAD KNEE I&D AND POLY EXCHANGE. POLY WAS REMOVED AND REPLACED. THERE WAS NO DELAY AND NO COMPLAINTS. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22223092 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION FROM FALL. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 19624407 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION LINER EXCHANGE DUE TO INFECTION. LINER WAS REMOVED AND A NEW ONE USED. DOI: ON (B)(6) 2023. DOR: ON (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17171852 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULDN¿T GET FULL EXTENSION SO THE SURGEON DETERMINED A THINNER POLY INSERT WOULD CORRECT THE FLEXION CONTRACTURE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Loss of Range of Motion

  MAUDE report 16662775 ↗
• InjurySep 14, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT FELL AT HOME AND DISLOCATED HER KNEE WHICH HAS ATTUNE REVISION COMPONENTS IMPLANTED. THEY REPLACED THE INSERT. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 15417826 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I & D AND POLY EXCHANGE WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12771771 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GLOBAL INSTABILITY IN FLEXION AND EXTENSION. 16 CRS POLY REPLACED WITH 24MM POLY TO HELP PATIENT'S RANGE OF MOTION AND STABILITY ISSUES. NO LOOSENING AND SURGICAL DELAY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10538298 ↗
• InjuryFeb 5, 2020Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  REASON FOR REVISION; DISLOCATION. POLY EXCHANGE DUE TO DISLOCATION FROM INJURY.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9672478 ↗