ATTUNE 1517-10-806Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295056232), received between Aug 20, 2018 and Sep 24, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50891217 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  Revision of Attune revision implants due to an infection. All implants had to be removed to treat the infection.Side Affected: Right Side.

  Patient problems: Unspecified Infection

  MAUDE report 50281364 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT DEVICES THAT WERE IMPLANTED IN 14 AUG 2025 ARE STILL IMPLANTED IN THE PATIENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25177135 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POLY SWAP AND WASHOUT FOR INFECTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24004842 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING DATE OF EVENT: 06 OCT 2025, DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23452370 ↗
• InjuryJul 7, 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. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22411179 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE HIS MCL AND REQUIRED A HINGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22356407 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED FOR INFECTION. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22309592 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY INSERT WAS REMOVED DUE TO PATIENT BEING UNABLE TO REACH FULL EXTENSION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21775898 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT AS PER SURGEON, THE PATIENT HAD NICKEL ALLERGY. SURGEON REMOVED ALL COMPONENTS AND PUT IN COMPETITOR'S NICKEL FREE IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20831276 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH KNEE WASH OUT DUE TO INFECTION. SURGEON SWAPPED POLY SIZE 8 6MM CRS RP INSERT. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20723613 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NEEDED BIGGER SIZE IMPLANT. SURGICAL DELAY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20577056 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION RIGHT TOTAL KNEE. PATIENT CAME IN FOR AN I&D POLY SWAP BECAUSE SHOWING SIGNS OF AN INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18442943 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16673243 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN I&D WASH OUT ,TO PREVENT INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15806826 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2021. THE REVISION DATE FOR THE LOOSENING AND INFECTION IS (B)(6) 2021. (THIS WAS DOCUMENTED IN THE EVENT DESCRIPTION AS (B)(6) 2021 BUT THIS WAS A CLERICAL ERROR). THE REVISION DATE FOR THIS PC IS (B)(6) 2021. ALL IMPLANTS WERE REVISED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14012986 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL IMPLANTS REMOVED SECONDARY TO INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13096499 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1. PLEASE CONFIRM PRESENCE OF INFECTION? BACTERIA HAVE BEEN GROWN FROM THE SAMPLES TAKEN AT THE TIME OF REMOVING THE ATTUNE REVISION , INDICATING AN INFECTION. 2. WAS LOOSENING DUE TO INFECTION? YES. 3. IT WAS INDICATED IN THE EVENT DESCRIPTION THAT '' THE TIBIA APPEARS TO HAVE MOVED/ SUBSIDED ON THE MEDIAL SIDE WITH THE LONG 160MM CANAL FILLING STEM (LONG STEM WAS REQUIRED TO BYPASS THE ORIGINAL STEM) ABUTTING THE LATERAL CORTEX WHICH SHOWS SIGNS OF REMODELING. '' PLEASE CLARIFY, DID THE TIBIA SUBSIDE? YES IT DID. MOVING INTO VARUS WITH THE DISTAL TIP ABBUTTING THE DISTAL LATERAL CORTEX. 4. CAN YOU PLEASE ADVISE WHO THE MANUFACTURER OF THE PATELLA WAS. I WOULD GUESS IT WAS A ZIMMER BIOMET PATELLA.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12780574 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND INSTABILITY, SUBJECTIVELY WORSE ON STAIRS WEAKNESS SUPPORTING KNEE AND HIP MUSCLES. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12691238 ↗
• MalfunctionDec 28, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AT THE END OF THE CASE, WHEN TRYING TO REDUCE THE REVISION KNEE, THE INSERT WOULD NOT FULLY SEAT IN THE TIBIA. DOE: UNKNOWN, UNKNOWN AFFECTED SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078639 ↗
• InjuryAug 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7797023 ↗