ATTUNE 1516-30-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295047865), received between Nov 7, 2017 and Aug 14, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Unintended Movement

  It was reported that Liner spun out due to instability.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right.

  Patient problems: Joint Laxity

  MAUDE report 50256810 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ASEPTIC REVISION WAS PERFORMED FOR INSTABILITY. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25636192 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED A TKR. REASON FOR REVISION WAS PAIN AND LOOSENING. SURGEON REMOVED FEMUR, TIBIA AND POLY INSERT IMPLANTS WHICH WERE WELL FIXED AND IN GROWN. CEMENTLESS FEMUR APPEARED TO BE IMPLANTED IN FLEXED POSITION WHICH LEFT A GAP BETWEEN THE ANTERIOR DISTAL FEMORAL BONE AND THE IMPLANT. POSTERIOR FEMUR HAD VERY GOOD BONE IN GROWTH AND WAS DIFFICULT TO REMOVE. ATTUNE REVISION IMPLANTED. PATELLA WAS LEFT IN-SITU. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 22877017 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR KNEE LAXITY. POLY WAS REVISED AND UPSIZED FROM 5MM TO 7MM TO HELP OVERALL STABILITY. THERE WAS NO BROKEN INSTRUMENT AND NO DELAYS. THERE WAS NO HARM TO PATIENT. DOI: (B)(6) 2020, DOR: (B)(6) 2025 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21902066 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SLIPPED, PCL LOSS OF INTEGRITY, CONVERSION TO PS. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21425750 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO STIFF KNEE. SURGEON REMOVED SCAR TISSUE AND EXCHANGED INSERT. UNKNOWN SURGICAL DELAY. ORIGINAL IMPLANT DATE UNKNOWN.

  Patient problems: Muscular Rigidity; Scar Tissue

  MAUDE report 20400199 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED, DUE TO AN UNBALANCED KNEE. THE SURGEON DID SOFT TISSUE WORK AND UPSIZED THE POLY THICKNESS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19724272 ↗
• InjuryJan 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE KNEE WAS REVISED FOR LOOSENING, INFECTION AND TUMOR. UNDER THE TIBIAL BASEPLATE. THE POLY INSERT LOOKED VERY GOOD WITH LITTLE WEAR ON TOP OR BOTTOM. TIBIAL TRAY WAS WELL FIXED WITH CEMENT COMPLETELY ADHERED TO THE UNDER SURFACE OF THE TRAY. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: REVISION OF LOOSE TIBIAL TRAY. ACTIVITY LEVEL: MODERATE.

  Patient problems: Unspecified Infection

  MAUDE report 18551908 ↗
• InjuryDec 19, 2023Naturally Worn; Naturally Worn

  THE PATIENT HAD A COMPLETE KNEE REPLACEMENT INCLUDING A 38MM PATELLA ATTUNE KNEE IN (B)(6) 2019. IT HAD TO BE REVISED IN 2021 AND AGAIN IN 2023. ON (B)(6) 2021, THE PATIENT HAD A LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY AND ¿GENERAL LOOSENING PROSTHESIS¿. PATHOLOGY REPORTS FROM THE SURGERY NOTED THE PATIENT HAD TISSUE REACTION FROM POLYETHYLENE DEBRIS. THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT WERE REMOVED AND COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATELLA WAS LEFT IN-SITU. (B)(4). IN 2023, THE PATIENT WAS REVISED TO ADDRESS PAIN, GIANT CELL REACTION, TISSUE REACTION DUE TO POLYETHYLENE DEBRIS. ONLY THE DEPUY PATELLA WAS REVISED. COMPETITOR PATELLA WAS IMPLANTED ALONG WITH COMPETITOR CEMENT DURING THIS PROCEDURE. (B)(4). DOI: (B)(6) 2019 DOR: 2023 LEFT PATELLA ONLY. DOI: (B)(6) 2019. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18356860 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SITE WAS THE LEFT SIDE. THE FRACTURED PART WAS THE FEMORAL BONE.

  Patient problems: Pain

  MAUDE report 18325522 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS EXPLANTED FOR INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18140701 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. THE SURGEON REMOVED THE CEMENTLESS RP TIBIA AND INSERT, REVISING TO A REVISION TIBIA AND CR INSERT. THE TIBIA WAS NOT LOOSE, BUT IT DID NOT APPEAR TO BE FULLY INGROWN. THE IMPLANTS WERE UNAVAILABLE FOR RETURN. THERE WERE NO COMPLAINTS OR DELAYS IN THE PROCEDURE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17851535 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION AS THE SURGEON REVISED THE KNEE TO A REVISION CONSTRUCT FOR KNEE STABILITY. THE IMPLANTS WERE WELL FIXED AND SIZED APPROPRIATELY ACCORDING TO THE SURGEON. NO INFORMATION IS AVAILABLE ON WHAT CEMENT WAS USED FOR THE PATELLA. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17832735 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS STIFFNESS. POLY WAS EXCHANGED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17780370 ↗
• InjuryMar 15, 2023Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PROVIDE THE X-RAY IMAGE WHICH WAS MENTIONED IN THE EVENT DESCRIPTION? NO IMAGE INTENSIFIER WAS USED FOR THE REDUCTION. B. WAS THERE ANY REVISION SURGERY PERFORMED? IF YES, CAN YOU PLEASE PROVIDE THE REVISION DATE? NO REVISION IS REQUIRED AT THIS TIME AS THE POLY WAS REDUCED. C. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? IF YES, PLEASE PROVIDE THE PATIENT'S HARM. NO D. WHAT WAS THE AFFECTED SIDE INVOLVED? LEFT E. DID THE INSERT ROTATE OR DID THE INSERT BECOME COMPLETELY DISLOCATED FROM THE TRAY? THE POLY ROTATED THROUGH 90 DEG.

  Patient problems: Insufficient Information

  MAUDE report 16544371 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 18.2 MONTHS. REASON FOR REVISION: LOOSENING/OSTEOLYSIS/PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 16370894 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 3 MONTHS. REASON FOR REVISION: INFECTION"

  Patient problems: Unspecified Infection

  MAUDE report 16364097 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR MORGAN REVISED AN ATTUNE PRIMARY TODAY FOR INSTABILITY. HE DID NOT DO THE PRIMARY CASE AND REVISED WITH ZIMMER SO NONE OF OUR PRODUCTS WERE USED. DR MORGAN STATED THE INDEX SURGERY LIKELY TOOK TOO MUCH OFF THE DISTAL FEMUR WHICH LED TO TIGHT FLEXION AND LOOSE EXTENSION GAPS. HE STATED IT WAS TECHNIQUE RELATED NOT IMPLANT RELATED. THE PRIMARY PROCEDURE WAS DONE BY DR COOKE ON THE 15/10/20 BUT UNKNOWN HOSPITAL. I DO NOT HAVE THE LOT NUMBERS AS WE COULD NOT READ THEM, WILL TRY TO GET DETAILS FROM CUSTOMER SERVICE.

  Patient problems: Joint Laxity

  MAUDE report 15872844 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TOTAL KNEE ARTHROPLASTY. ALL COMPONENTS WERE REMOVED AND REVISED TO AN FB ATTUNE REVISION CONSTRUCT WITH A STRYKER CONE AND CEMENTED STEMS. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15806010 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION AND KNEE PAIN. AFTER TRIALING SURGEON DECIDED TO UPSIZE INSERT AND PUT IN A SZ6 X 6 MM INSERT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15752194 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DETAILS: EVENT: MUA FOR RT KNEE ARTHROFIBROSIS. EVENT DATE: (B)(6) 2021. EVENT DAY: 41. SITE AWARENESS DATE: 20 DEC 2021. IF EVENT DATE IS EQUAL TO DATE OF PRIMARY STUDY PROCEDURE, WHEN DID EVENT OCCUR?: PRIOR TO PROCEDURE. ALERT DATE: 02 FEB 2022. EVENT OCCURRED: POST-OP. COUNTRY OF EVENT: US. SUBJECT COHORT: MANUAL. OPERATIVE SIDE: BLANK. ROBOTIC CASE ID: BLANK. DATE OF TOTAL KNEE ARTHROPLASTY: (B)(6) 2021.

  Patient problems: Adhesion(s)

  MAUDE report 15137980 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15028944 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS REVISING THE KNEE DUE TO STABILITY REASONS. SALES REP WAS NOT IN ACTUAL SURGERY BECAUSE SURGEON USED A COMPETITIVE REVISION IMPLANT. SURGEON DID NOT PROVIDE ANY ADDITIONAL INFORMATION AFTER REVISION. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14497118 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS GROWING A STAPH INFECTION. REMOVAL OF IMPLANTS WAS IN ORDER TO PLACE AN ANTIBIOTIC SPACER TO HELP CLEAR THE INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13569599 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT CAME IN WITH A MID FLEXION INSTABILITY. SURGEON DECIDED IT BEST TO REMOVE THE PORO CR FEMUR, DOWNSIZE THE FEMUR AND INCREASE THE POLY THICKNESS TO BALANCE THE KNEE. SURGEON REMOVED THE SIZE 6 RIGHT CR PORO FEMUR AND POLY. PUT BACK IN A 5 RIGHT CR CEMENTED FEMUR AND A 5X12 RP CR POLY. WHILE PUTTING THE POLY BACK IN, THE PCL WAS RUPTURED SO SURGEON WENT UP TO A 5X14 RPCR. WHILE DOING THIS, SURGEON RESURFACED THE NATIVE PATELLA AND PUT IN A 38 DOME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN; DOR: (B)(6) 2022; RIGHT KNEE. (B)(4) ARE LINKED PC'S.

  Patient problems: Joint Laxity

  MAUDE report 13442889 ↗