ATTUNE AFFIXIUM 1506-21-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295507475), received between Apr 14, 2023 and Sep 28, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain. No loosening, nothing further to report.Affected Side: Left Knee.

  Patient problems: Pain

  MAUDE report 50913621 ↗
• InjuryJun 8, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT REPORTS A PAINFUL TKA. ALL LABS NORMAL. SURGEON REMOVED TIBIAL INSERT AND TRAY. SAYS THE TRAY SHOWED EVIDENCE OF "PARTIAL INGROWTH." REPLACED WITH A CEMENTED FB REV TRAY. IT WAS STATED THAT TIBIAL COMPONENT WAS LOOSE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 25431733 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED KNEE, ALL COMPONENTS REMOVED. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23959879 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23933895 ↗
• InjuryNov 12, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23536002 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ATTUNE FEMORAL COMPONENT, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22666773 ↗
• 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 21766574 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024.DARTHMOUTH 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21028129 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE IMPLANT REMOVAL PROCEDURE DUE TO INFECTION. DOI: (B)(6) 2024. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20736624 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL PRIMARY COMPONENTS WERE REMOVED DUE TO INFECTION & SOFT TISSUE DAMAGE FROM THE PATIENT FALLING. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20632249 ↗
• InjuryOct 8, 2024Migration; Migration

  IT WAS REPORTED THAT THE TIBIAL COMPONENT HAD COLLAPSED DOWN ON MEDIAL SIDE. THERE WAS NO SURGICAL DELAY. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20398447 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ASPIRATION; 20 CC OF BLOOD ASPIRATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16742343 ↗