ATTUNE 1516-40-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295049852), received between Dec 7, 2017 and Jun 17, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FALL AND RUPTURED HER PATELLA TENDON THAT WAS REPAIRED ON (B)(6) 2019. THE SIZE 4X16MM ATTUNE PS FIXED INSERT WAS REMOVED AND NEW INSERT THE SAME SIZE WAS PLACED IN. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8703417 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED TOTAL KNEE WAS IRRIGATED AND POLY WAS EXCHANGED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7096458 ↗

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