ATTUNE 1516-00-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295421559), received between Apr 19, 2022 and Oct 31, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMES BACK FOR AN EXPLANT FOR INFECTION AND REIMPLANT OF AN ANTIBIOTIC SPACER. FULL REVISION WILL BE PERFORMED ONCE INFECTION HAS CLEARED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20578500 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES RECEIVED. THE PATIENT UNDERWENT A REVISION OF HER RIGHT KNEE ON (B)(6) 2024 DUE TO CHRONIC INFECTION OVER THE PAST 6 MONTHS CAUSING PAIN AND SWELLING. RADIOGRAPHIC CHANGES SHOW RESORPTIVE CHANGE UNDER THE TIBIA. INTRAOPERATIVELY, SYNOVITIS WAS FOUND AND A BAKER CYST WAS IDENTIFIED THAT HAD BEEN INFECTED. THERE WAS ALSO A CYST SOMEWHAT IN THE LATERAL GUTTER WITH INFECTED TYPE TISSUE WHICH WAS DEBRIDED. THE ENTIRE PROSTHESIS WAS REMOVED AND AN ANTIBIOTIC LOADED SPACER WAS PLACED.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Pain; Swelling/ Edema; Synovitis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20556220 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022 (RIGHT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 14144449 ↗