ATTUNE 1504-11-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295041900), received between Nov 22, 2019 and Aug 7, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Dartmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysis.Reason for revision: Revision due to stiffness and pain.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50173171 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LCL WAS TORN AND NOT REPAIRABLE. SURGEON REMOVED COMPONENTS AND CONVERTED TO SROM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20678887 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO 45 DEGREE FLEXION CONTRACTURE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Joint Contracture

  MAUDE report 18697558 ↗
• InjuryAug 11, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN AND LOOSENING. THERE WAS A LOOSENING OF FEMUR AND TIBIA AT BONE TO IMPLANT INTERFACE. IT WAS UNKNOWN IF ANY SURGICAL DELAY REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15211629 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AND INFECTION FOR UNKNOWN REASONS. COMPONENTS WERE EXPLANTED AND ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12306501 ↗
• MalfunctionMay 26, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ATTUNE PS PRESS FIT FEMUR COULD NOT BE IMPACTED TO SEAT FULLY ON THE FEMUR. NO MATTER HOW HARD IT WAS IMPACTED, IT SAT UP 3-5 MM OFF THE DISTAL FEMUR. THERE WAS A SURGICAL DELAY OF 10-15 MINUTES. DOE: (B)(6) 2021, LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886278 ↗
• MalfunctionDec 9, 2019Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SIGNIFICANT LEFT PATELLAR CREPITUS EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE). PRODUCT DETAILS: COMPONENT TYPE: ATTUNE PS FEM LT SZ 5 POR, CATALOG NUMBER: 150411105, PRODUCT ID/LOT NUMBER: 8895851. COMPONENT TYPE: ATTUNE RP TIB BASE SZ 5 POR, CATALOG NUMBER: 150611005, PRODUCT ID/LOT NUMBER: 8723506. COMPONENT TYPE: ATTUNE PS/RP INSERT SZ 5 10MM, CATALOG NUMBER: 151650510, PRODUCT ID/LOT NUMBER: 8491845. COMPONENT TYPE: ATTUNE MEDIAL DOME PAT 35MM, CATALOG NUMBER: 151820035, PRODUCT ID/LOT NUMBER: 8925641. COMPETITOR BONE CEMENT UTILIZED AT PRIMARY.

  Patient problems: Anxiety; Discomfort; Edema; No Code Available; Pain

  MAUDE report 9440098 ↗
• MalfunctionNov 22, 2019Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OEDEMA LOWER LEG LEFT IN LIMITED RANGE OF MOTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT KNEE).

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9363197 ↗