ATTUNE 1516-40-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295049500), received between Jun 24, 2022 and Mar 2, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT RECEIVED A PRIMARY LEFT KNEE ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2024, THE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS CONFIRMED TO BE LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. TIBIAL BONE OSTEOLYSIS WAS CURETTED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE PATELLA WAS WELL FIXED AND RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 24484874 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(4) IS RELATED TO (B)(4). (B)(4) REPORTS REGARDING THE RECONSTRUCTION SURGERY WHICH WAS PERFORMED AFTER THE PRIMARY SURGERY DUE TO THE PATELLAR TENDON TEAR. THIS (B)(4) REPORTS REGARDING THE REVISION SURGERY WHICH WAS PERFORMED AFTER THE RECONSTRUCTION SURGERY DUE TO THE INFECTION OF THE PERI-LIGAMENTOUS. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE LIGAMENT RECONSTRUCTION SURGERY DUE TO THE PATELLAR TENDON TEAR. TWO WEEKS AFTER THE RECONSTRUCTION SURGERY, IT WAS FOUND THAT THE PERI-LIGAMENTOUS WAS INFECTED. THEREFORE, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. IN THE REVISION SURGERY, DEBRIDEMENT WAS PERFORMED, AND THE ARTIFICIAL LIGAMENT WAS REMOVED. NEXT, THE ATTUNE INSERT WAS REPLACED WITH A NEW INSERT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 14800059 ↗

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