ATTUNE 1504-01-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295041511), received between Dec 13, 2018 and Apr 3, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THERE WAS NO OTHER ISSUE, NO IMPLANT MALFUNCTION, NO LOOSENING, NO OTHER COMPLAINTS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21766566 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18796639 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION RIGHT TOTAL KNEE. PATIENT HAD FALLEN AND PATIENT WAS HAVING PAIN IN KNEE. SURGEON EXPLANTED THE IMPLANTS AND REVISED TO ATTUNE REVISION IMPLANTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 17817265 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PRIMARY ATTUNE KNEE REPLACEMENT ON THE (B)(6) 2021 (NO PATELLA RESURFACING DONE DURING PRIMARY SURGERY). THE PATIENT HAS BEEN COMPLAINING OF GROWING ANTERIOR KNEE PAIN AND SOME SWELLING. SURGEON ELECTED TO RE-OPERATE AND RESURFACE THE PATELLA. DURING THIS PROCEDURE IT WAS ALSO NOTED THAT THE PATIENT HAD SIGNIFICANT SYNOVITIS WHICH WAS DEBRIDED AT THE TIME OF SURGERY.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15793827 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12546309 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO LOOSENING REPORTED. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11773631 ↗
• InjuryNov 4, 2019Adverse 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 KNEE 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; (RIGHT KNEE).

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9273935 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EARLY ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: (B)(6) 2018 (RIGHT KNEE).

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9166219 ↗
• InjuryMar 18, 2019Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8429692 ↗
• InjuryFeb 4, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8302705 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. ORIGINAL ATTUNE CEMENTLESS CR RP IMPLANTS WERE IMPLANTED ON (B)(6) 2018 BY DIFFERENT SURGEON.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8159973 ↗