ATTUNE 1547-06-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295382775), received between Apr 26, 2019 and Apr 20, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 5, 2022Class IITerminated

   May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

   Z-0632-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE WHEN WALKING AND REQUIRED REVISION SURGERY DUE TO LOOSENING OF IMPLANTS. THE REVISION PROCEDURE WAS PERFORMED TO ADDRESS PAIN AND IMPLANT LOOSENING AT AN UNKNOWN INTERFACE, AND ALL AFFECTED IMPLANTS WERE EXPLANTED AND DISCARDED. PATIENT HAD 3 PREVIOUS REVISIONS ON THIS KNEE.

  Patient problems: Pain

  MAUDE report 24927606 ↗
• InjuryApr 20, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE WHEN WALKING AND REQUIRED REVISION SURGERY DUE TO LOOSENING OF IMPLANTS. THE REVISION PROCEDURE WAS PERFORMED TO ADDRESS PAIN AND IMPLANT LOOSENING AT AN UNKNOWN INTERFACE, AND ALL AFFECTED IMPLANTS WERE EXPLANTED AND DISCARDED. PATIENT HAD 3 PREVIOUS REVISIONS ON THIS KNEE.

  Patient problems: Pain

  MAUDE report 24927576 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN & INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24366537 ↗
• InjurySep 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE SLEEVE, STEM, AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. REMOVED ALL FEMUR IMPLANTS AND DID NEW. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23016894 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22948081 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22948048 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20589021 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20589020 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE TO A FRACTURED FEMUR POST INITIAL SURGERY. THE ORIGINAL IMPLANT SURGERY WAS AN UNKNOWN DATE IN 2020. THERE WAS NO SURGICAL DELAY AND NO ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20303126 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN ATTUNE REV KNEE CONSTRUCT WAS IN. IT WAS REVISED WITH A SINGLE STAGE REIMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20145055 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN ATTUNE REV KNEE CONSTRUCT WAS IN. IT WAS REVISED WITH A SINGLE STAGE REIMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20145050 ↗
• InjuryMar 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 PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Pain

  MAUDE report 18893244 ↗
• InjuryMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL LOOSENING OF THE STUDY KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2019, DATE OF REVISION: ON (B)(6) 2023, DATE OF EVENT: 30 AUG 2023, (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL DISTAL AUGMENT, FEMORAL POSTERIOR AUGMENT, AND TIBIAL INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18835924 ↗
• InjuryMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL LOOSENING OF THE STUDY KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION:(B)(6) 2023. DATE OF EVENT: 30 AUG 2023. (LEFT KNEE).

  Patient problems: Insufficient Information

  MAUDE report 18835922 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE REPLACEMENT IN 2022 DUE TO INFECTION. THE PATIENT PRESENTED TO THE CLINIC AGAIN IN FALL 2023. A FURTHER REVISION DUE TO AN INFECTION IS PLANNED FOR (B)(6) 2024. A SEPARATE COMPLAINT FOR THE FIRST REVISION WAS FILED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18433963 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE REPLACEMENT IN 2022 DUE TO INFECTION. THE PATIENT PRESENTED TO THE CLINIC AGAIN IN FALL 2023. A FURTHER REVISION DUE TO AN INFECTION IS PLANNED FOR (B)(6) 2024. A SEPARATE COMPLAINT FOR THE FIRST REVISION WAS FILED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18414063 ↗
• InjuryOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PATIENT PRESENTED FOR REVISION OF UNI COMPARTMENTAL TO TOTAL KNEE ARTHROPLASTY. PRIOR TO IMPLANTATION OF IMPLANTS ALL IMPLANTS WHERE VERIFIED WITH OPERATING SURGEON, CIRCULATING NURSE AND SALES REPRESENTATIVE. IMPLANTS WHERE IMPLANTED AFTER BEING DELIVERED TO FIELD BY CIRCULATING NURSE. UPON INVESTIGATION OF REPRESENTATIVE BILLING SHEET, PRIOR TO PLACING TIBIAL INSERT, SALES REP DISCOVERED THAT THE FEMORAL IMPLANT WAS NOT FOR THE CORRECT SIDE. OPERATIVE SIDE AS (RIGHT) IMPLANT USED WAS (LEFT). SURGEON WAS NOTIFIED IMMEDIATELY, AND FEMORAL COMPONENT WAS SURGICALLY REMOVED. CORRECT IMPLANTS WHERE THEN PRESENTED TO THE SURGICAL FIELD AND IMPLANTED AT THIS TIME. THERE WAS NO HARM TO PATIENT. SURGICAL TIME WAS EXTENDED DUE TO REMOVAL OF FEMORAL IMPLANT. ALL EVENTS OCCURRED INTRAOPERATIVELY BEFORE PATIENT LEFT THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961186 ↗
• InjuryDec 5, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  3RD REVISION. ATTUNE REVISION FEMUR LOOSENING.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15914559 ↗
• InjuryDec 5, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  3RD REVISION. ATTUNE REVISION FEMUR LOSENING. PATIENT STATUS/OUTCOME/CONSEQUENCES.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15914353 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION, ATTUNE SPACER PUT IN ITS PLACE. IMPLANTS RETAINED BY HOSPITAL. NO OTHER CONSEQUENCES TO PATIENT. PRIMARY SURGERY DATE IS UNKNOWN, FIRST REVISION SURGERY DATE (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15873912 ↗
• InjuryNov 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND TIBIAL SLEEVE BEING LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15870763 ↗
• InjuryNov 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND TIBIAL SLEEVE BEING LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15870692 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MEDICAL RECORDS FROM (B)(6) 2022 NOTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION COMPLETED ON (B)(6) 2022. AFTER THE REVISION, THE PATIENT HAD ERYTHEMA OVER THE INCISION AND A STITCH ABSCESS WAS CUT OUT. PATIENT REPORTS HAVING PAIN DUE TO THE SUPERFICIAL INFECTION". NOTE: THE PATELLA WAS LEFT IN SITU DURING (B)(6) 2022 REVISION.

  Patient problems: Abscess; Erythema; Pain; Unspecified Infection

  MAUDE report 15257775 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MEDICAL RECORDS FROM (B)(6) 2022 NOTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION COMPLETED ON (B)(6) 2022. AFTER THE REVISION, THE PATIENT HAD ERYTHEMA OVER THE INCISION AND A STITCH ABSCESS WAS CUT OUT. PATIENT REPORTS HAVING PAIN DUE TO THE SUPERFICIAL INFECTION". THE PATELLA WAS LEFT IN SITU DURING (B)(6) 2022 REVISION.

  Patient problems: Abscess; Erythema; Pain; Unspecified Infection

  MAUDE report 15257765 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018; DATE OF EVENT: (B)(6) 2021; (LEFT KNEE). TREATMENT: INJECTED MEDICATION; DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 15198522 ↗