ATTUNE 1517-10-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295056034), received between Dec 19, 2018 and Jan 26, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (3 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Device Dislodged or Dislocated

  PATIENT THAT MAY REQUIRE A CUSTOM KNEE IMPLANT. THE PATIENT CURRENTLY HAS AN ATTUNE REVISION CONSTRUCT WHICH THE SURGEON PLANS TO SWAP OUT FOR A HINGE PROSTHESIS DUE TO RECURRENT SUBLUXATION OF THE INSERT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 24183246 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE REASON FOR REVISION? WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS/CONSEQUENCE THAT LED TO THE REVISION SURGERY? - INFECTION.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24177729 ↗
• InjuryNov 4, 2025Adverse 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 Q3 OF 2025. 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 ARTHROFIBROSIS AND LOOSE FEMUR. NON-ARTICULAR SURFACE OF FEMORAL COMPONENT SHOWED ABUNDANT CEMENT REMAINING. UNKNOWN CEMENT MANUFACTURER.

  Patient problems: Adhesion(s)

  MAUDE report 23463910 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21296779 ↗
• InjuryJan 13, 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 THE PAINFUL TKA. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21139440 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 20168811 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY SWAP. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19760317 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO LARGER COMPONENTS TO TREAT PAIN SECONDARY TO A FALL. DOI: (B)(6) 2023. DOR: (B)(6) 2024. RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 18923718 ↗
• 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 18414188 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY SWAP DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18191960 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE INFECTION. ATTUNE REVISION RIGHT. CHANGE MOBILE PARTS AND WASH. DOI: (B)(6) 2022. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16263579 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15969010 ↗
• InjuryJul 29, 2022Unintended Movement; Unintended Movement

  THIS (B)(4) IS RELATED TO (B)(4) AND (B)(4). (B)(4) REPORTS THAT SPIN OUT OCCURRED AFTER THE PRIMARY SURGERY. PC-001164844 REPORTS THAT SPIN OUT OCCURRED AGAIN AFTER THE REOPERATION. THIS PC REPORTS THAT THE REOPERATION WAS PERFORMED WITHOUT WOUND OPENING. IT WAS REPORTED THAT ON (B)(6) 2022, THE REOPERATION WAS PERFORMED. THE SURGEON USED THE IMAGE INTENSIFIER UNDER ANESTHESIA AND TRIED TO ATTEMPT MANUAL REDUCTION. THE SURGEON SUCCEEDED REDUCTION, SO THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT WOUND OPENING. AT THE TIME OF REDUCTION, THE SURGEON REQUESTED THAT THE INSERT SHOULD HAVE HAD AN ANTEROPOSTERIOR INDICATOR UNDER THE X-RAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 15130593 ↗
• InjuryJul 21, 2022Unintended Movement; Unintended Movement

  THIS (B)(4) IS RELATED TO (B)(4) AND (B)(4). (B)(4) REPORTS THAT SPIN OUT OCCURRED AFTER THE PRIMARY SURGERY. (B)(4) REPORTS THAT THE REOPERATION WAS PERFORMED WITHOUT WOUND OPENING. THIS PC REPORTS THAT SPIN OUT OCCURRED AGAIN AFTER THE REOPERATION. IT WAS REPORTED THAT ON (B)(6) 2022, SPIN OUT WAS CONFIRMED BY X RAYS. THE SURGEON PLANNED TO PERFORM MANUAL REDUCTION UNDER NON-ANESTHESIA. THE SURGEON ASKED THE SALES REP IF HE SHOULD PERFORM THE OPEN REDUCTION AND REPLACE THE INSERT, ALTHOUGH HE DID NOT KNOW THE OPEN REDUCTION WOULD BE SUCCESSFUL. IF THE INSERT IS TO BE REPLACED, A REVISION SURGERY WAS SCHEDULED ON (B)(6) 2022. ON (B)(6) 2022, MANUAL REDUCTION WAS PERFORMED, AND IT WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS PLACED IN A CAST IN THE EXTENDED POSITION, AND THE SURGEON WILL FOLLOW UP THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 15074786 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT SEEMED THAT SPIN OUT OCCURRED. MANUAL REDUCTION WAS PERFORMED, AND IT WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS PLACED IN A CAST IN THE EXTENDED POSITION, AND THE SURGEON WILL FOLLOW UP THE PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14852171 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY SWAP WAS DONE AND POLY WAS DOWNSIZED TO A 6MM. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 12285726 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT "PAIN WITH LEVEL WALKING = 8".

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12189553 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY AND IT WAS CONFIRMED THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

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

  MAUDE report 11948015 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTION IN HIS KNEE, ALL IMPLANTS REMOVED, SURGEON STATED THE INFECTION WAS THE SAME BUG THAT REQUIRED HIS PRIMARY IMPLANTS TO BE REMOVED IN THE FIRST PLACE. UNSURE IF THE IMPLANTS REMOVED FROM THE PRIMARY WERE OURS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9973705 ↗
• MalfunctionApr 7, 2020Difficult to Insert; Difficult to Insert

  REVISION KNEE REPLACEMENT: (B)(6) HOSPITAL, (B)(6) 2020. SURGEON TRIALLED WITH A 10MM INSERT WITH NO DIFFICULTIES. WHEN TRYING TO INSERT DEFINITIVE SURGEON COULD NOT INSERT. DELAY FOR 5MINS PRIOR TO INSERTING. NO AE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9933119 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED A WASHOUT AND EXCHANGE OF IMPLANTS FOR INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9933082 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE SURGEON WASHED THE KNEE OUT AND DID A POLYSWAP. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9315695 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8273460 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8181157 ↗