ATTUNE 1516-40-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295050018), received between Feb 21, 2018 and Aug 7, 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 16, 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.

• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION ON (B)(6) 2017 DUE TO PAIN AND INSTABILITY. THE PRODUCTS WERE NOTED TO BE WELL FIXED. ALL PRODUCTS WERE REVISED. COMPETITOR CEMENT WAS USED DURING THE FIRST REVISION OPERATION. DOI: (B)(6) 2015 (PATELLA AND FEMUR); DOI: (B)(6) 2017; DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8871417 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7285630 ↗

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