ATTUNE 1516-40-312Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295049692), received between Sep 28, 2020 and Nov 27, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY SWAP DURING IRRIGATION AND DEBRIDEMENT (I/D) FOR INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20799757 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE WAS REVISED DUE TO INSTABILITY. PATIENT ATTUNE SIZE 3 FB PS 12MM TIBIAL INSERT WAS REMOVED AND REPLACED BY A THICKER SIZE 3 FB PS 16MM TIBIAL INSERT. THIS PATIENT'S KNEE HAD PREVIOUSLY BEEN REVISED BY A SURGEON ON 12 AUG 19 AT (B)(6) MEDICAL CENTER. DURING THAT PROCEDURE, SURGEON CONVERTED PATIENT'S UNICOMPARTMENTAL KNEE TO A TOTAL KNEE. DOI: (B)(6) 2019; DOR: (B)(6) 2021 ; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12696462 ↗
• MalfunctionSep 28, 2020Expiration Date Error; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10594183 ↗

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