ATTUNE 1517-10-722Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295056201), received between Apr 8, 2020 and Nov 12, 2025 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTION IN HIS LEFT KNEE JOINT WHERE A PREVIOUSLY IMPLANTED TOTAL KNEE REPLACEMENT WAS PRESENT. THE SURGEON ELECTED TO REMOVE AND REPLACE THE POLYETHYLENE INSERT IMPLANT AND DO A THOROUGH WASH OUT. THERE WAS NO REPORT OF HARM OR DELAY LEFT SIDE. DOI- (B)(6) 2022. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23535354 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22148969 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTED LTKA. SURGEON EXPLANTED THE ATTUNE REVISION IMPLANTS WE IMPLANTED ON (B)(6) 2023. THEY WASHED OUT THE KNEE IMPLANTED JUST A ATTUNE REV FEMORAL COMPONENT AND ATTUNE INSERT ALONG WITH SOME ANTIBIOTIC CEMENT SPACER AND ANTIBIOTIC BEADS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368298 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED AS "SURGEON THOUGHT FEMUR WAS LOOSE BECAUSE PATIENT WAS EXPERIENCING PAIN. UPON INSPECTION AND REMOVAL OF FEMUR IT WAS FOUND THAT THE FEMUR WAS WELL FIXED AND THAT THE KNEE NEEDED TO BE CLEANED UP FROM OSTEOPHYTES THAT MAY HAVE BEEN CAUSING THE PAIN WHEN THE KNEE ROTATED. THE FEMORAL SLEEVE WAS COVERED IN BONE GROWTH AND WAS WELL FIXED. SURGEON IMPLANTED A SROM HINGE FEMUR." NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12438194 ↗
• InjuryApr 8, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 STATING THAT THE INFECTION HAS NOT BEEN CONFIRMED AND IS NOT THE CAUSE OF INSTABILITY. IT WAS CAUSED BY A KNEE DISLOCATION SUSTAINED WHEN THE PATIENT WAS KICKED IN THE KNEE WHILE IN PRISON. NO ALLEGATION OF FAULT STATED BY THE SURGEON AGAINST THE PRODUCTS.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 9934294 ↗