ATTUNE 1504-01-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295041344), received between Jul 30, 2019 and Jul 22, 2026 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 25903726 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY PATIENT CONSEQUENCE/S RELATED TO THE EVENT? -YES. B. KINDLY CONFIRM THAT IT WAS A FEMUR FRACTURE, AND ASK HOW IT WAS TREATED (LONGER STEM? CERCLAGE CABLES?) -CABLES AND LONG PLATE AND SCREWS.

  Patient problems: Limb Fracture

  MAUDE report 24176429 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED TOTAL KNEE. SURGEON TOOK OUT OLD PARTS AND PUT IN A SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24114515 ↗
• MalfunctionSep 16, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ATTUNE CEMENTLESS FEMUR (POROCOAT) WAS VERY GRIPPY, REQUIRES LARGE AMOUNT OF FORCE TO IMPACT IT IN TO SEAT ON THE RESECTED BONY SURFACE. THERE WAS A CONCERN ABOUT MICROFRACTURES GIVEN THE STRONG IMPACTION REQUIRED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062784 ↗
• InjuryApr 29, 2025Adverse 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 PAIN. UNKNOWN SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21925965 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21859582 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO.

  Patient problems: Joint Laxity

  MAUDE report 20350822 ↗
• InjuryDec 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD AN ATTUNE TOTAL KNEE REPLACEMENT ON (B)(6) 2023 IN THE SWAH. ON OR AROUND (B)(6) 2023 THEY SUFFERED A DISLOCATED KNEE AND WENT TO THEATRE FOR AN URGENT CLOSED REDUCTION OF DISLOCATED KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 18388604 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS OF THE LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2018. (LEFT KNEE). TREATMENT: I&D, SYNOVECTOMY, ARTHROLYSIS AND PHYSICAL THERAPY.

  Patient problems: Adhesion(s)

  MAUDE report 18004918 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LARGE MEDIAL HEMATOMA ON LEFT KNEE AT INCISION SITE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT (ONSET): (B)(6) 2017; (LEFT KNEE). TREATMENT: MEDICAL INTERVENTION/MODIFICATION: SURGICAL ASPIRATION AND EVACUATION OF HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 14014760 ↗
• MalfunctionJan 19, 2022Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  ISSUE WITH THE PACKAGING: THEY COULDN'T PROPERLY OPEN IT AND TAKE OUT THE IMPLANT. IMPLANT DIDN'T COME INTO CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13291468 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS OF THE LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2017 (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Adhesion(s)

  MAUDE report 12907616 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS RECURRENT INFECTION. THE IMPLANTS WERE EXPLANTED AND SWITCHED TO ANTIBIOTIC SPACER. THE POLY WAS SWAPPED ON (B)(6) 2020. DOI: (B)(6) 2020 (FEMUR, PATELLA AND TIBIA), DOI: (B)(6) 2020 (INSERT), DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11342643 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10191284 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR COLLAPSE OF THE TIBIAL METAPHYSEAL BONE WITH INCREASED SLOPE OF THE TIBIAL COMPONENT AND POSTERIOR SUBLUXATION OF THE FEMORAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT (ONSET): (B)(6) 2018; (LEFT KNEE).

  Patient problems: Failure of Implant

  MAUDE report 8842896 ↗