ATTUNE 1523-07-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295057673), received between Jan 14, 2021 and Oct 25, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND INSTABILITY, SUBJECTIVELY WORSE ON STAIRS WEAKNESS SUPPORTING KNEE AND HIP MUSCLES. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12691105 ↗
• InjuryOct 18, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF INSERT, AND BOTH TIBIAL AND FEMORAL REVISION CONSTRUCTS.

  Patient problems: Insufficient Information

  MAUDE report 12646809 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE INFECTIONS AT THE UNKNOWN CAUSES. DOI: (B)(6) 2019; (B)(6) 2020 (POLY EXCHANGE DUE TO INSTABILITY CAPTURED IN (B)(4)) DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11171616 ↗