ATTUNE 1516-40-814Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295050407), received between Dec 11, 2019 and May 1, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16843504 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15155784 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT PAIN SECONDARY TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE DISCOMFORT SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON EXCISED ARTHROFIBROSIS. THE TIBIAL TRAY WAS LOOSENED AT AN UNKNOWN INTERFACE AND REVISED. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT RECEIVED AN UNKNOWN REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Adhesion(s); Discomfort; No Code Available

  MAUDE report 10508344 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A 2ND LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT AND INSTABILITY. THE SURGEON REPORTED THE FEMORAL AND PATELLAR COMPONENTS WERE WELL-FIXED, WELL POSITIONED AND NOT REVISED. HE INDICATED THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE AND IN RELATIVE VARUS POSITION. THE SURGEON REPORTED REMOVING LOOSE UNSTABLE CEMENT. HE INDICATED INSTABILITY TO THE KNEE PRIOR TO THE REVISION. THE PATIENT WAS IMPLANTED WITH DEPUY REVISION SYSTEM AND COMPETITOR CEMENT.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 9452595 ↗

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