ATTUNE 1516-41-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295050667), received between May 10, 2018 and May 4, 2022 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LINER EXCHANGE DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14278243 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN ER WITH SIGNS OF INFECTED LT KNEE. THE SURGEON PREFORMED AN I AND D AND POLY EXCHANGE. DOI: (B)(6) 2017. DOR: (B)(6) 2021, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 12896450 ↗
• 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 8460094 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2018, DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7502613 ↗

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