ATTUNE 1506-00-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 10603295042372), received between Jul 5, 2017 and Sep 23, 2026 — classified as 267 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (214 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 271 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Loss of or Failure to Bond

  It was reported that patient had primary total knee by the doctor in 2016. Aseptic loosening of the tibia component and now she needed a complete revision. The femur was well fixated with good cement to metal bonding. Implants removed without issue. Tibia was completely loose and was removed with no cement on the component. First generation Attune primary tibia had been implanted. Attune Revision components used today. The loosening interface was marked as cement to implant. Cement Manufacturer was competitor.Affected side-Left knee.

  Patient problems: Insufficient Information

  MAUDE report 50867227 ↗
• InjuryApr 1, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A ASEPTIC LOOSENING OF THE RIGHT TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE, RESULTING IN PAIN AND NECESSITATING REVISION SURGERY WITH EXPLANTATION OF THE DEVICE. THE CEMENT USED WAS NOT MANUFACTURED BY DEPUY SYNTHES.

  Patient problems: Pain

  MAUDE report 24757478 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO INFECTION. DURING THE FIRST STAGE OF WHAT WILL BE A TWO STAGE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY AN ANTIOBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 24302157 ↗
• InjuryDec 1, 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 LOOSENING OF ATTUNE FIXED BEARING TIBIAL BASEPLATE SIZE 3 AT BONE TO CEMENT INTERFACE. PATIENT REVISED ATTUNE PRIMARY COMPONENTS BECAUSE THE PATIENT DEVELOPED A CYST UNDERNEATH THE TIBIAL BASEPLATE. BECAUSE OF THE CYST THE TIBIAL BASEPLATE BECAME LOOSE. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Cyst(s)

  MAUDE report 23682657 ↗
• InjuryJul 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE AND HAD A PAINFUL KNEE. TIBIAL TRAY WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22676863 ↗
• InjuryDec 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED, THAT ON (B)(6) 2015. THE PATIENT, UNDERWENT A TKA WITH THE ATTUNE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED, DUE TO LOOSENING OF THE TIBIAL TRAY. THE SURGEON GUESSED, THAT THE CAUSE OF THE LOOSENING WAS, DUE TO DEBONDING OF FORMER MODEL TRAY AND ERROR OF CEMENT PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20871907 ↗
• InjuryNov 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AND PATELLA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20663278 ↗
• InjuryNov 6, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  MEDICAL RECORDS RECEIVED AD 29 OCT 2024: IT WAS REPORTED ON (B)(6) 2015: 54-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. REVISION SURGERY OCCURRED (B)(6) 2019: 57-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT CEMENT TO IMPLANT INTERFACE WITH MIGRATION INTO VARUS AND EXTENSIVE TIBIAL BONE LOSS, AND REVISED. SURGEONS NOT THERE WAS A PARTIALLY HEALED TIBIAL CONDYLE FRACTURE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND THE PATELLA WAS RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Adhesion(s); Bone Fracture(s); Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 20622461 ↗
• InjuryOct 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL TRAY BETWEEN CEMENT AND IMPLANT. THERE WAS NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398579 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY INVOLVING ATTUNE COMPONENTS. THE PATELLA WAS RESURFACED AND SMARTSET CEMENT X 2 WAS USED. ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT KNEE REVISION FOR INSTABILITY. INTRAOPERATIVELY, THE TIBIAL COMPONENT WAS COMPLETELY DEBONDED AT AN UNKNOWN INTERFACE. THE PATIENT HAD SEVERE OSTEOLYSIS AND A TIBIAL PLATEAU FRACTURE. THE FRACTURE WAS REPAIRED WITH A SMALL TRABECULAR METAL CONE AND BONE GRAFTS. COMPETITOR PRODUCTS WERE PLACED DURING THE REVISION WHILE THE ATTUNE PATELLA WAS LEFT IN SITU. DOI: (B)(6) 2015. DOR: (B)(6) 2024 (LEFT KNEE).

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 19637069 ↗
• InjuryMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2015. DATE OF REVISION: (B)(6) 2024. (LEFT KNEE). TREATMENT: TIBIAL BASE AND INSERT REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18836127 ↗
• InjuryJan 30, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LOOSENING INTERFACE WAS FROM TIBIA TO CEMENT. THE CEMENT USED IS ALSO UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18606690 ↗
• InjuryJan 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS LOOSENING OF ATTUNE CEMENTED TIBIAL BASEPLATEINTERFACE CEMENT/IMPLANT.WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO,WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN,WERE FRAGMENTS GENERATED? --> UNKNOWN,IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN,PATIENT STATUS/ OUTCOME / CONSEQUENCES --> ,WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN,IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE,DEVICE IN POSSESSION OF -->NONEBY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE

  Patient problems: Insufficient Information

  MAUDE report 18517695 ↗
• InjurySep 21, 2023Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  MEDICAL RECORDS RECEIVED AD 8 SEP 2023 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2017, THE PATIENT HAD BILATERAL TKR TO ADDRESS BILATERAL END-STAGE OSTEOARTHROSIS. DEPUY COMPONENTS, INCLUDING DEPUY PATELLAS WERE IMPLANTED DURING THESE PROCEDURES. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED. ON (B)(6) 2022 -REVISION LEFT TOTAL KNEE TO ADDRESS LOOSENING OF PROSTHESIS, PAIN AND INSTABILITY. PREOPERATIVE RADIOGRAPHS WERE REPORTED TO SHOW ASEPTIC LOOSENING. DURING THE PROCEDURE, THE SURGEON REMOVED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT. PATELLA WAS LEFT IN-SITU. THERE WAS SUBSTANTIAL BONE LOSS AT THE TIBIAL EPIPHYSIS. PATHOLOGY REPORT NOTES INSCRIPTION ON THE TIBIAL PLATE IS (B)(6) LOT 85273810, AND THAT THERE WAS YELLOWISH DISCOLORATION, MULTIPLE DEEP SCRATCHES AND FOCAL DELAMINATION ON THE INSERT. (DID NOT MENTION IF THIS WAS FROM REMOVAL OF IMPLANT ETC) THE PATHOLOGY REPORT ALSO NOTED CHRONIC INFLAMMATION, FOREIGN BODY GIANT BODY CELL PROLIFERATION CONSISTENT WITH POLYETHYLENE AND METALLIC DEBRIS. COMPETITOR PRODUCTS IMPLANTED DURING THIS PROCEDURE. IT SHOULD BE NOTED, THAT THERE WAS NO MENTION OF A SPECIFIC LOOSE COMPONENT OR INTERFACE IN THE REVISION NOTES DOI: (B)(6) 2017

  Patient problems: Foreign Body Reaction; Inflammation; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 17789732 ↗
• InjuryMay 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT. THERE WAS A LOOSENING REPORTED IN ATTUNE TIBIA BASE AT CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16857363 ↗
• InjuryApr 20, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT WAS REVISED DUE TO SUBSIDENCE AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE FROM PRIOR PRIMARY TOTAL KNEE REPLACEMENT. CEMENT MANUFACTURER IS UNKNOWN. SURGEON MENTIONED THAT OLDER ATTUNE TIBIAL BASE IMPLANTS HAD ISSUE/DEFICIENCY WITH CEMENTED FIXATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16775467 ↗
• InjuryApr 19, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AND SUBSIDENCE AT CEMENT TO IMPLANT INTERFACE . THE PATIENT'S PRIMARY ATTUNE FIXED BEARING TIBIAL BASE AND CRUCIATE RETAINING FIXED BEARING INSERT WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. THERE WAS NO CEMENT ATTACHED TO THE UNDERSIDE OF THE TIBIAL BASE, WHICH WOULD SUGGEST THAT THERE WAS A FLAW IN THE DESIGN OF THE TIBIAL BASE ACCORDING TO THE SURGEON DEPUY SMARTSET GMV BONE CEMENT WAS USE DURING THE PRIMARY PROCEDURE. THE LOT NUMBERS FOR THE CEMENT USED IS NOT AVAILABLE, SINCE IT WAS ORDERED DIRECTLY FROM DEPUY BY THE HOSPITAL. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16770935 ↗
• MalfunctionMar 20, 2023Migration; Migration

  PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY UTILIZING ATTUNE IMPLANTS ON (B)(6) 2017. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS USED. CLINIC NOTES FROM APPROXIMATELY (B)(6) 2023 INDICATE THE PATIENT HAS NUMBNESS AND 7/10 PAIN THAT COMES AND GOES IN RELATION TO THE WEATHER. THE LEFT KNEE IS IN VARUS ALIGNMENT UPON GENERAL ASSESSMENT. XRAY SHOWS THE TIBIAL COMPONENT IN 7 TO 10 DEGREES OF VARUS. THE SURGEON PLANS TO CONTINUE TO OBSERVE THE PATIENT AT THIS TIME. DOI: (B)(6) 2017; NO FURTHER INTERVENTION.

  Patient problems: Numbness; Pain

  MAUDE report 16572161 ↗
• InjuryMar 17, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY OUR PATIENT THAT "ATTUNE KNEES GERMANY ORIGINAL SURGERY (B)(6) 2014 BILATERAL. REVISION SURGERY IN TEXAS DR. LEFT SIDE IN 2019 APPROXIMATELY (B)(6) (WAS NOT SUCCESSFUL). REVISION ON LEFT (B)(6) 2020 IN (B)(4). REVISION SURGERY IN RIGHT IN (B)(6) OF 2021 (B)(4)."

  Patient problems: Joint Laxity

  MAUDE report 16564108 ↗
• InjuryMar 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY OUR PATIENT THAT. SHE FOUND MY NAME/NUMBER ON FDA¿S RECALL SITE. SHE WANTED TO KNOW IF HER ATTUNE KNEES IMPLANTED IN GERMANY WERE RECALLED. ATTUNE KNEES GERMANY ORIGINAL SURGERY (B)(6) 2014 BILATERAL REVISION SURGERY IN TEXAS LEFT SIDE IN 2019 APPROXIMATELY (B)(6) (WAS NOT SUCCESSFUL) REVISION ON LEFT (B)(6) 2020. REVISION SURGERY IN RIGHT IN (B)(6) OF 2021. PATIENT INDICATED SHE UNDERWENT BILATERAL TKAS WITH ATTUNE IMPLANTS ON (B)(6) 2014 IN GERMANY. SHE UNDERWENT A REVISION OF HER LEFT KNEE IN 2019 FOR INSTABILITY AND TIBIAL TRAY LOOSENING (UNKNOWN INTERFACE OR CEMENT MFG INVOLVED). ALL IMPLANTS WERE REMOVED AND ITS UNKNOWN WHAT IMPLANTS (MANUFACTURER) WERE PLACED AS REVISION. SHE UNDERWENT A REVISION OF HER RIGHT KNEE IN (B)(6) OF 2021 FOR INSTABILITY AND TIBIAL TRAY LOOSENING (UNKNOWN INTERFACE FOR CEMENT MFG INVOLVED). ALL IMPLANTS WERE REMOVED AND ITS UNKNOWN WHAT IMPLANTS (MANUFACTURER) WERE PLACED AS REVISION. THE PATIENT IS SEEKING RECALL INFORMATION. PATIENT WAS INFORMED THE PART/LOT INFORMATION OF THE IMPLANTS PLACED IN 2014 IS NEEDED. PATIENT INDICATED SHE HAS THIS INFORMATION AND PROVIDE US WITH THIS INFORMATION. PATIENT

  Patient problems: Joint Laxity

  MAUDE report 16551665 ↗
• InjuryFeb 15, 2023Migration; Migration

  REVISION COMPLETED DUE TO FAILED TKA, AS A RESULT OF TIBIAL COMPONENT SUBSIDENCE. DUE TO THE SUBSIDENCE OF THE ORIGINAL BASEPLATE, A REVISION OF THE TIBIAL COMPONENTS WAS REQUIRED. THE ORIGINAL SIZE 3 ATTUNE FIXED BEARING TIBIAL BASEPLATE WAS REMOVED ALONG WITH THE SIZE 4 X 5MM FIXED BEARING POLYETHYLENE INSERT. A SIZE 4 ATTUNE RP REVISION TIBIA BASEPLATE ALONG WITH A 37MM FULLY POROUS COATED TIBIAL SLEEVE AND 16 X60MM PRESS FIT STEM WAS USED TO REPLACE THE ORIGINAL FAIL TIBIAL COMPONENTS. A 4 X 16MM CR/RP POLYETHYLENE INSERT ACHIEVED THE BEST FLEXION AND EXTENSION BALANCE AND WAS ALSO IMPLANTED. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16378925 ↗
• InjuryFeb 13, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF TIBIA. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2015. DATE OF REVISION: (B)(6) 2023 DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE) . TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 16364011 ↗
• InjuryDec 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. THE REPORTED LOOSENING WAS CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. IT WAS UNKNOWN IF ANY SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15995631 ↗
• InjuryDec 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15983299 ↗
• InjuryOct 13, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: 2016; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15595485 ↗