ATTUNE 1516-41-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295050674), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.

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.

• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT XRAYS REVEALED A LOOSE TIBIAL COMPONENT WITH MILD OSTEOLYSIS. THE SURGEON STATED THAT THERE WAS NO CEMENT ADHERENCE TO THE TIBIAL COMPONENT. DOI: (B)(6) 2015. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 9266392 ↗

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