ATTUNE 1506-00-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 10603295042402), received between Jul 21, 2017 and Apr 21, 2026 — classified as 286 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (203 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 287 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: LOOSE TIBIAL TRAY

  Patient problems: Insufficient Information

  MAUDE report 24941772 ↗
• InjuryApr 7, 2026Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT PATIENT¿S TIBIAL TRAY HAD COLLAPSED INTO VARUS. WHEN THE TRAY WAS REMOVED, THE UNDERSIDE HAD LOOSENED FROM THE CEMENT. THE FEMORAL IMPLANT WAS ALSO REMOVED; THERE WAS NO FEMORAL LOOSENING. IT WAS STATED THAT TIBIAL TRAY WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. DOI: ON (B)(6) 2015, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24800266 ↗
• InjuryDec 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LEFT TOTAL KNEE, LOOSENING OF TIBIA AND LOOSENING OF FEMUR WAS REPORTED AT UNKNOWN INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23866532 ↗
• InjuryNov 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ATTUNE PS FB KNEE. THERE WAS A LOOSENING OF ATTUNE FB TIBIA AT CEMENT TO IMPLANT INTERFACE AND CEMENT MANUFACTURE WAS COMPETITOR. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23476810 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT APPEARED TO BE OCCURRING FOR A WHILE. SURGEON DECIDED TO REMOVE IMPLANTS IMPLANT AN ANTIBIOTIC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23393835 ↗
• InjuryJun 27, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT WAS REVISED DUE TO FAILED TIBIA. IT WAS SUBSIDED. THERE WAS A LOOSENING OF TIBIAL PLATE AT CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22350467 ↗
• InjuryApr 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF BOTH HIS PRIMARY FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DURING THE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. THERE WAS NO CEMENT REMAINING ON THE EXPLANTED COMPONENTS. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21925823 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PREVIOUS ATTUNE PS FIXED BEARING RIGHT TOTAL KNEE DONE AT UNKNOWN DATE, LOCATION AND SURGEON. PATIENT CAME IN FOR REVISION SURGERY FOR INSTABILITY. FEMUR, TIBIA, AND INSERT WERE REMOVED AND ATTUNE RP REVISION COMPONENTS IMPLANTED. THERE WAS NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20693284 ↗
• InjuryNov 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2016, PATIENT RECEIVED AN ATTUNE RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS. THEY RECEIVED A SIZE 7 POSTERIOR STABILIZED FEMUR, A SIZE 6 TIBIAL TRAY, A 6MM THICK INSERT, AND 38MM PATELLA, ALL USING DEPUY SMARTSET HV CEMENT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2020, PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS ASEPTIC IMPLANT LOOSENING OF TIBIA AND FEMUR. INTRAOPERATIVELY, THE TIBIAL BASEPLATE WAS FOUND TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE; SURGEON REPORTED THAT THERE WAS NO CEMENT ADHERED/BONDED TO THE BACKSIDE OF THE TIBIAL TRAY AT ALL. THE FEMUR WAS ALSO LOOSE AND EXPLANTED AS WELL; THERE WAS CEMENT BONDED TO THE FEMUR COMPONENT. THE FEMUR LOOSENING INTERFACE WAS BOTH CEMENT TO IMPLANT AND CEMENT TO BONE LOOSENING. THE PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. SURGEON RE-IMPLANTED COMPETITOR PRODUCTS, WITH NO REPORTED COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20631450 ↗
• InjuryMay 17, 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 KNEE PAIN. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19341553 ↗
• InjuryMay 15, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT WAS REVISED DUE TO THE LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE AND MEDIAL COLLAPSE. THE FEMUR WAS NOT LOOSE AND DISASSOCIATED AT THE BONE/CEMENT INTERFACE. DOI: (B)(6) 2013 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19319729 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:(B)(6). STUDY NO: DPO_10004_10008 CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN LEFT KNEE- ASPIRATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2013 DATE OF EVENT: (B)(6) 2014 (LEFT KNEE) TREATMENT: MEDICAL INTERVENTION/MODIFICATION.

  Patient problems: Pain

  MAUDE report 19221700 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY WITH A FEMORAL AUTOLOGOUS BONE GRAFTING ON (B)(6) 2017 TO ADDRESS PAIN, AND PSORIATIC ARTHRITIS. ON (B)(6) 2023, LEFT KNEE WAS REVISED TO ADDRESS PAIN, RECURRENT PATIENT FALLS AND LEFT KNEE INSTABILITY, WITH REPLACEMENT OF TIBIAL AND FEMORAL COMPONENTS TO COMPETITOR SYSTEM. THE PRIMARY PATELLA COMPONENT TRACKED WELL AND WAS RETAINED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 18544434 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED KNEE REVISION SURGERY. THIS WAS DUE TO FAILURE OF PRIMARY ATTUNE IMPLANTS IN SITU. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18383204 ↗
• InjuryOct 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS A LOOSENING OF TIBIAL COMPONENT WHICH LED TO THE REVISION OF PRIMARY TOTAL KNEE. THE ATTUNE TIBIAL TRAY WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER IS DEPUY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17868843 ↗
• InjurySep 26, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT EXPERIENCED PAIN AND INFLAMMATION. PATIENT UNDERWENT AN ATTUNE TIBIAL TRAY AND INSERT REVISION DUE TO LOOSENING.

  Patient problems: Inflammation; Pain

  MAUDE report 17822462 ↗
• InjurySep 7, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO MEDIAL COLLAPSE OF TIBIA PROSTHESES. AFTER THE TIBIA TRAY WAS REMOVED, CULTURES WERE TAKEN AND THE TIBIA WAS PREPPED FOR A REVISION TIBIAL TRAY, SLEEVE AND STEM. PATHOLOGY CALLED INTO THE ROOM AND STATED THERE WAS AN INFECTION PRESENT AND AN 16MM POLY SPACER WITH ANTIBIOTIC CEMENT WAS IMPLANTED. SURGICAL DELAY UNKNOWN. DOI: OCT 21, 2014. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17700335 ↗
• InjuryAug 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT ATTUNE TKA TO TREAT SEVERE ARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT SUSPECTED TIBIA TRAY LOOSENING. UPON ENTERING THE JOINT, METALLOSIS, SYNOVITIS, AND SCAR TISSUE WERE DEBRIDED. THE FEMORAL COMPONENT WAS WELL-FIXED AND ALIGNED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE EXPLANTED TIBIAL INSERT SHOWED SIGNS OF MINIMAL WEAR AND OXIDATION. THE REVISED TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS WELL-FIXED WITH SIGNS OF MINIMAL WEAR BUT RETAINED. THE PATIENT RECEIVED A DEPUY ATTUNE REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Adhesion(s); Foreign Body Reaction; Synovitis

  MAUDE report 17540736 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AT 3 MONTHS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT #MW5119538, #MW5119539, #MW5119541. DOI: (B)(6) 2014. DOR: (B)(6) 2014. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17469114 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT HAD A LEFT KNEE ARTHROSCOPY WITH 3 COMPARTMENT SYNOVECTOMY AND DEBRIDEMENT, MANIPULATION UNDER ANESTHESIA FOR THE LEFT KNEE TO ADDRESS ARTHROFIBROSIS OF THE LEFT KNEE. THERE WERE NO COMPONENTS REVISED. DOI:(B)(6) 2017. DOE: (B)(6) 2018. AFFECTED SIDE: LEFT KNEE. THIS IS A LINK OF (B)(4).

  Patient problems: Adhesion(s)

  MAUDE report 16843224 ↗
• InjuryApr 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2017, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY END-STAGE VALGUS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA, AND DEPUY CEMENT X1 WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2022, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TO ADDRESS FAILED LEFT TOTAL KNEE, ARTHROFIBROSIS, LIMITED RANGE OF MOTION, AND ASEPTIC LOOSENING OF THE TIBIAL TRAY. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE TIBIAL TRAY HAD DEBONDED FROM THE CEMENT. THE FEMORAL COMPONENT AND INSERT WERE REVISED WITH NO ALLEGATION OF DEFICIENCY. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI :(B)(6) 2017 DOR: (B)(6) 2022 (LEFT KNEE). THIS IS A LINK OF (B)(4).

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

  MAUDE report 16831071 ↗
• InjuryApr 18, 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: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16760773 ↗
• InjuryDec 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISION DUE TO LOOSENING OF TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15953065 ↗
• InjuryAug 24, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO KNEE PAIN AND THE TIBIA LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15283786 ↗
• InjuryAug 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. FULL REVISION PERFORMED LEAVING PATELLA IMPLANT IN PLACE. DOI: (B)(6) 2014. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15217089 ↗