ATTUNE 1516-41-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295050650), received between Nov 22, 2023 and Nov 22, 2023 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2023Expiration Date Error; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE ANY PATIENT HARM RELATED TO THE EVENT? NO. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. C. WAS THERE A REVISION SURGERY? NO. D. CAN YOU PLEASE PROVIDE THE AFFECTED SIDE? LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190532 ↗

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