ATTUNE 1516-20-607Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295045786), received between Nov 22, 2017 and Aug 12, 2026 — classified as 35 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient originally had a Uni conversion total Knee. Due to Poor bone quality, a revision was performed with increased fixation using a stem, augment, and cone.DOI: UnknownDOR: (b)(6), 2026Affected side: Right

  Patient problems: Bone Notching

  MAUDE report 50226295 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A QUAD PARTIAL TEAR AND SURGEON WANTED NEW POLY. DOI-UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24059974 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WASHOUT AND TIBIAL INSERT EXCHANGED FOR A POTENTIAL INFECTION. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24037648 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 23924403 ↗
• InjuryJul 30, 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 Q2 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: THE ATTUNE FEMORAL COMPONENT, TIBIAL INSERT, AND TIBIAL TRAY WERE REVISED FOR ARTHROFIBROSIS, INSTABILITY, AND PAIN.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 22671532 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME DRAINAGE FROM THE KNEE AND SURGEON ELECTED TO DEBRIDE THE KNEE AND CHANGE INSERT. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22560628 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PROGRESSIVE INSTABILITY OVER THE LAST YEAR OR SO. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22518644 ↗
• MalfunctionJan 10, 2025Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124194 ↗
• InjuryNov 11, 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 STIFF KNEE. EXCHANGED INSERT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 20653858 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO: DSJ-2016-03 CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 10 APR 2019 . DEVICE LOCATION: RIGHT TREATMENT/IMPACT: : CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 20471372 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D WITH POLY SWAP WAS PERFORMED. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18812596 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POLY SWAP AND OPEN LYSIS. SWAPPED TO MS FROM STANDARD CR/FB. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 18764224 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INSERT OF THE PATIENT WAS EXCHANGED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17965964 ↗
• MalfunctionJul 21, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS WAS NOT A REVISION. THE IMPLANT REPORTED WAS NEVER IMPLANTED. THE SURGEON ATTEMPTED TO IMPLANT IT, BUT IT WOULD NOT SEAT WHEN IMPACTED, SO HE USED A SECOND IMPLANT THAT SEATED PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 17369909 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17331887 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16843112 ↗
• MalfunctionFeb 20, 2023Difficult to Insert; Difficult to Insert

  PATIENT WAS REVISED DUE TO POLY WOULD NOT SEAT/LOCK COMPLETELY IN BASEPLATE. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403573 ↗
• MalfunctionJan 19, 2023Difficult to Insert; Difficult to Insert

  THE INSERT WAS IMPACTED ONTO THE TIBIA TRAY BEING FULL SEATED BUT STILL LOOSENS OUT VERY EASILY. THERE WAS A TWO MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16204160 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS INDICATE A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY UTILIZING ATTUNE IMPLANTS. THE PATELLA WAS RESURFACED AND SMARTSET GMV CEMENT WAS USED. PATIENT WAS LATER REVISED FOR GLOBAL INSTABILITY AND TIBIAL COMPONENT MALALIGNMENT. WHILE THE SURGEON STATES THE TIBIAL COMPONENT WAS EASY TO REMOVE, HE STATES THE FEMORAL, PATELLA, AND TIBIAL TRAY WERE ALL WELL-FIXED. THE FEMORAL COMPONENT, INSERT, AND TRAY WERE REVISED. DOI: (B)(6) 2015. DOR: (B)(6) 2022. (RIGHT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 15969980 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 WITH DEPUY SYNTHES IMPLANTS INCLUDING A RESURFACED PATELLA. CEMENT WAS COMPETITOR. PATIENT THEN HAD PAIN AND INSTABILITY REQUIRING A RIGHT REVISION SURGERY ON (B)(6) 2022. INTRAOPERATIVE FINDINGS WERE A LOOSE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2013. DOR: (B)(6) 2022 (RIGHT KNEE).

  Patient problems: Joint Laxity; Pain

  MAUDE report 15840621 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 14643108 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION RIGHT TOTAL KNEE REPLACEMENT FOR INSTABILITY, EVIDENCE OF HAEMARTHROSIS AND STAINED "THOUGHT TO BE BLOOD" SYNOVIUM. BEARING CHANGED TO THICKER BEARING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Joint Laxity

  MAUDE report 14166821 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS PAIN AND STIFFNESS. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF REVISION: (B)(6) 2021. (RIGHT KNEE) TREATMENT: REVISION OF TIBIAL TRAY AND TIBIAL INSERT.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13387275 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIBIA HAD COLLAPSED ON THE LATERAL SIDE AND THE PATIENT ACCORDING TO THE REVISION SURGEON SAID THAT THE PATIENT MUST HAVE FALLEN. SURGEON BELIEVED THE MCL WAS COMPROMISED. SURGEON REMOVED ALL COMPONENTS AND FELT THAT PUTTING A HINGE TKA WAS BEST FOR THE PATIENT MOVING FORWARD. PATIENT HAD A PRIMARY LT TKA DONE 7-1-2019, PATIENT THAT TIME HAD "SOFT BONE" ACCORDING TO THE PRIMARY SURGEON. THE SURGEON FELT THAT PUTTING IN A STEM ON TIBIA TRAY WAS BEST FOR PATIENT AND 2 YEARS LATER THE PATIENT NEEDS A REVISION. PATELLA WAS NOT REMOVED. DOI: (B)(6) 2019; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 12301425 ↗
• InjuryJul 6, 2021Noise, Audible; Noise, Audible

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE, ARTHROFIBROSIS, AND DECREASED RANGE OF MOTION. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. AD (B)(6) 2021: LITIGATION RECORD RECEIVED. LITIGATION RECORD ALLEGES SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY, POPPING AND CLICKING OF DEVICE, DIFFICULTY AMBULATING, LOSS OF MOBILITY, LOSS OF RANGE OF MOTION, MENTAL ANGUISH, LOOSENING AND MIGRATION OF THE TIBIAL COMPONENT DOI: (B)(6) 2014, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 12124192 ↗