ATTUNE 1516-40-716Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295050278), received between Jul 29, 2019 and Oct 12, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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.

• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. TIBIAL INSERT WAS SWAPPED. DOI: UNKNOWN. DOR: (B)(6) 2020. UNKNOWN KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10664434 ↗
• InjuryAug 29, 2019Naturally Worn; Naturally Worn

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, SYNOVITIS, FLEXION CONTRACTURE, POLY WEAR, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Joint Disorder; No Code Available; Pain; Synovitis

  MAUDE report 8945234 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DER WAS RECEIVED WITH EVENT DESCRIPTION OF "REMOVAL OF ANTIBIOTIC SPACER AND PLACEMENT OF ATTUNE REVISION KNEE SYSTEM BECAUSE THE INFECTION HAD BEEN CLEARED" DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8836420 ↗

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