ATTUNE 1516-41-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295050629), received between Aug 27, 2018 and Sep 21, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT I&D OF THE KNEE, AND THE POLY WAS EXCHANGED FOR THE SAME SIZE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17789814 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 3.7 MONTHS. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16371106 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE INSTABILITY AND PAIN IN WHOLE LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: ORAL MEDICATION AND PHYSICAL THERAPY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16123391 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. SURGEON DID AN I&D WITH POLYSWAP. DOI: UNKNOWN DOR: (B)(6), 2022 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14427370 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT ADVANCED TRICOMPARTMENTAL OSTEOARTHRITIS OF THE RIGHT KNEE. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. RECORDS INDICATE THE PATIENT RECEIVED A REVISION OF THE RIGHT KNEE. THE INDICATIONS FOR THE REVISION AND THE COMPONENTS REVISED ARE UNKNOWN. THERE WERE NO REVISION OPERATIVE NOTES PROVIDED. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9865057 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 07 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO ARTHRITIS AND PAIN. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE DEPUY KNEE SYSTEM AND COMPETITOR¿S BONE CEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT A STAGE 1 REVISION WITH A TEMPORARY KNEE SPACER AND MEDIAL GASTRIC FLAP RAISED INSET OVER SPACER, DUE TO INFECTION. ALL COMPONENTS WERE REMOVED, AND ANTIBIOTIC SPACER PLACED. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017; DOR: (B)(6) 2017; (LT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9254916 ↗
• InjuryJun 20, 2019Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED 23 JUL 2018. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. PATIENT UNDERWENT A LEFT TKA WITH DEPUY CEMENT. THE PATELLA WAS NOT RESURFACED. THE PATIENT THEN UNDERWENT A REVISION FOR PAIN AND TIGHTNESS. INTRAOPERATIVE FINDINGS INCLUDED CHRONIC INFLAMMATION, TIGHTNESS/SCARRING REQUIRING A QUADRICEPS SNIP FOR BETTER VISUALIZATION, LOOSENING OF THE TIBIAL TRAY AT IMPLANT-CEMENT INTERFACE, AND A PITTED INSERT. DOI: (B)(6) 2015; DOR: (B)(6) 2017; (LEFT).

  Patient problems: Inflammation; No Code Available; Pain; Scarring

  MAUDE report 8718248 ↗
• MalfunctionSep 14, 2018Defective Device; Defective Device

  INTRAOPERATIVELY THE ATTUNE TIBIAL INLAY DID NOT SNAP INTO THE TIBIA PLATEAU. ANOTHER INLAY WAS AVAILABLE AND USED WITHOUT ISSUES, SURGERY PROLONGATION ABOUT 7 MINUTES. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876802 ↗
• InjuryAug 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO PAIN AND STIFFNESS DOI: (B)(6) 2017; DOR: (B)(6) 2018; (LEFT KNEE).

  Patient problems: Not Applicable; Pain

  MAUDE report 7817993 ↗

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