ATTUNE 1516-20-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295045526), received between Jan 29, 2018 and Aug 6, 2026 — classified as 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Pain.DOI: Unknown. DOR: (b)(6) 2026.Affected Side: Right Knee.

  Patient problems: Pain

  MAUDE report 50159796 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION FOR STABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25027744 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24431476 ↗
• MalfunctionFeb 4, 2026Difficult to Insert

  IT WAS REPORTED THAT THE 4X5MM INSERT WOULD NOT SIT ON TIBIA, NEW INSERT WAS OPENED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257842 ↗
• MalfunctionAug 18, 2025Difficult to Insert; Nonstandard Device; Defective Device; Difficult to Insert; Nonstandard Device; Defective Device

  ADDITIONAL INFORMATION RECEIVED: A. DID THE PACKAGING APPEAR CRUSHED OR DAMAGED BEFORE IT WAS OPENED? IF YES, WAS IT DAMAGED BEFORE OR AFTER IT ARRIVED AT THE HOSPITAL? - NO. B. COULD THE INSERT HAVE BEEN EXPOSED TO ANY BLUNT FORCE ON THE POSTERIOR EDGE EITHER BEFORE OR DURING THE SURGERY? IF YES, PLEASE PROVIDE DETAILS - NO. C. FINALLY, CAN YOU SHARE ANY DETAILS OF THE TECHNIQUE THAT WAS USED TO INSERT THE POLY? - SURGEON DISLOCATED TIBIA AND ANGLE THE TIBIAL INSERT POSTERIORLY AND SLIDE THE POSTERIOR TABS INTO THE POSTERIOR UNDERCUTS OF THE TIBIAL BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825754 ↗
• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AFTER FALLING. DOCTOR EXCHANGED CRUCIATE RETAINING/ FIXED BEARING INSERT FOR A MEDIAL STABILIZED INSERT. INSERT EXCHANGED FROM FIXED BEARING CRUCIATE RETAINING TO A MEDIAL STABILIZED INSERT. AFFECTED SIDE: LEFT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22662946 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT POLY EXCHANGE FOR PERCEIVED INSTABILITY IN THE RIGHT KNEE. NO SURGICAL DELAY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22526939 ↗
• 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 TIGHT IN FLEXION AND EXTENSION. SURGEON DID SOME RELEASES AND WENT IN WITH A MS POLY DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21139427 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A LEFT KNEE REVISION SURGERY ON (B)(6) 2024 WHERE INSERT EXCHANGE OCCURRED DUE TO STIFF KNEE. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT UNKNOWN.

  Patient problems: Muscular Rigidity

  MAUDE report 20685612 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON DID A POLY SWAP BECAUSE THE KNEE WAS LOOSE. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20568338 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT NEEDED A REVISION TKR DONE DUE TO INFECTION OF THE KNEE. THE PRIMARY RIGHT KNEE WAS DONE ON THE (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 18952426 ↗
• InjuryFeb 15, 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 24.7 MONTHS. REASON FOR REVISION: INFECTION."

  Patient problems: Unspecified Infection

  MAUDE report 16378867 ↗
• 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 2.6 MONTHS. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16371152 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE REPLACEMENT. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16146633 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REVISED DUE TO PAIN. IMPLANTS WERE NOT LOOSE. DOI: UNKNOWN. DOR: UNKNOWN. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 13619635 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 13544059 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED LAXITY. POLY EXCHANGED PERFORMED SUCCESSFULLY. DOI: (B)(6) 2017. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12331960 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED BILATERAL ATTUNE TOTAL KNEES TO TREAT OSTEOARTHRITIS. THE RIGHT PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. PRE-OPERATIVE X-RAYS DEMONSTRATED A LATERALIZED PATELLA. ALL COMPONENTS WERE REVISED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11929730 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED BILATERAL ATTUNE TOTAL KNEES TO TREAT OSTEOARTHRITIS. THE LEFT PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, MISPOSITIONED FEMORAL COMPONENT, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. PRE-OPERATIVE X-RAYS DEMONSTRATED SUBLUXATION OF THE PATELLA. ALL COMPONENTS WERE REVISED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11929644 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME HEALTH ISSUES AND STARTED TO COMPLAIN OF SOME KNEE PAIN. HE SAID THAT HE DID A WORKUP AND FOUND OUT THAT HE HAD A KNEE INFECTION. THE SURGEON REMOVED ALL THE COMPONENTS AND USE SIGMA RP IMPLANTS AS A SPACER UNTIL THE INFECTION HEALED. THE IMPLANTS ARE WELL FIXED. THE SURGEON REMOVED ALL IMPLANTS EXCEPT FOR THE PATELLA BECAUSE HE WAS CONCERNED WITH THE AMOUNT OF BONE LOSS AND WHAT BONE WOULD BE LEFT TO WORK WITH. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11517619 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THE PRIMARY OPERATIVE NOTES WERE NOT AVAILABLE AT THE TIME OF REVIEW. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, STIFFNESS, DECREASED RANGE OF MOTION, AND ADHESIONS. A PRE-OPERATIVE CT SCAN DEMONSTRATED INTERNAL ROTATION OF THE TIBIAL COMPONENT CONCERNING FOR MALROTATION OF THE TIBIAL COMPONENT. WITHIN THE REVISION OPERATIVE NOTE THERE IS NO CONFIRMATION OF TIBIAL TRAY MISPOSITIONING. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017. DOE: (B)(6) 2017 RIGHT KNEE MANIPULATION (CAPTURED ON LINKED COMPLAINT). DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 11446557 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 02 FEB 2021 WERE REVIEWED. ON (B)(6) 2015, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT TRICOMPARTMENTAL KNEE OSTEOARTHRITIS. NO COMPLICATIONS WERE NOTED DURING THIS PROCEDURE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED. ON (B)(6) 2018, THE PATIENT HAD A REVISION TO ADDRESS ASEPTIC LOOSENING. THE INDICATIONS FOR SURGERY INCLUDED WORSENING PAIN, INSTABILITY AND PREOPERATIVE RADIOGRAPHS WERE REPORTED TO SHOW DISPLACEMENT OF THE TIBIAL COMPONENT WITH EVIDENCE OF LOOSENING OF THE FEMORAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED, ABUNDANT SYNOVITIS, EXTENSIVE EROSIONS AROUND THE JOINT IMPLANTS, THE FEMORAL COMPONENT WAS LOOSE AT THE COMPONENT/CEMENT INTERFACE. THE TIBIAL TRAY WAS LOOSE AT THE COMPONENT/CEMENT INTERFACE. THERE WAS LARGE EROSIONS/BONE LOSS. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THERE WAS NO ALLEGATION OF DEFICIENCY FOR THE PATELLA, AND NO MENTION OF REVISING IT. DOI: (B)(6) 2015. DOR: (B)(6) 2018 (LEFT KNEE).

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

  MAUDE report 11413754 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, AND ARTHROFIBROSIS. ALL COMPONENTS WERE WELL-FIXED AND ALIGNED. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. POST-OPERATIVE DIAGNOSIS INDICATED MECHANICAL LOOSENING, HOWEVER, NO MENTION OF LOOSENING OF ANY PARTICULAR COMPONENT WAS NOTED IN THE REVISION OPERATIVE NOTE. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Fibrosis; Joint Laxity; Pain

  MAUDE report 11400158 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE ARTICLE ENTITLED, ¿DOES CIRCUMFERENTIAL PATELLAR DENERVATION RESULT IN DECREASED KNEE PAIN AND IMPROVED PATIENT-REPORTED OUTCOMES IN PATIENTS UNDERGOING NON-RESURFACED, SIMULTANEOUS BILATERAL TKA?¿ BY NICOLAAS C. BUDHIPARAMA MD, ET AL, PUBLISHED BY CLINICAL ORTHOPAEDICS RELATED RESEARCH (2020), VOL. 428, PP. 2020-2033 WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF PATELLAR DENERVATION IN 78 PATIENTS RECEIVING BILATERAL ATTUNE PRIMARY TKAS WITHOUT PATELLAR RESURFACING BETWEEN FEB 2015 AND OCTOBER 2016. IN ALL BILATERAL PROCEDURES, THE PATELLAR DENERVATION VIA CAUTERIZATION OF THE PATELLAR RIM WAS ALWAYS PERFORMED ON THE RIGHT KNEE. THE AUTHORS CONCLUDED THAT THERE WAS NO CLINICAL DIFFERENCE BETWEEN THE CAUTERIZED AND NON-CAUTERIZED KNEES. PATIENT 2: DOI (B)(6) 2016. PATIENT RECEIVED A BILATERAL PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS OF KNEE GRADE 4. THE PATELLA WAS NO RESURFACED AND SMARTSET GENTAMYCIN CEMENT X1 WAS UTILIZED. SURGERY PERFORMED USING MEDIAL PARAPATELLAR STANDARD APPROACH AND HYBRID METHOD (MEASURED RESECTION + GAP BALANCING) USED FOR CUTTING AND ROTATIONAL REFERENCE TOWARD MECHANICAL AXIS. THE PROCEDURE WAS COMPLETED WITHOUT CO

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11186963 ↗
• InjuryNov 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AFTER SURGERY AND DISLOCATED HER KNEE. THE SURGEON WENT BACK IN AND PULLED THE CR FEMUR AND INSERT AND REPLACED WITH A PS FEMUR AND PS INSERT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10792975 ↗