ATTUNE 1516-41-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295050636), received between Mar 28, 2019 and Sep 7, 2022 — classified as 2 injuries, 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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.

• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15369390 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC JOINT INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE . EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE) TREATMENT: DIAGNOSTIC INTERVENTION - ASPIRATION OF RIGHT KNEE FOR CULTURES ; IV ANTIBIOTICS FOR 6 WEEKS.\; SURGICAL INTERVENTION - I&D OF KNEE WITH INSERT EXCHANGE, ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 12576582 ↗
• MalfunctionMar 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ATTUNE OUTSIZER KIT - WAS FOUND TO HAVE EXPIRED IMPLANTS IN THE SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459800 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507