ATTUNE 1504-10-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10603295041849), received between Aug 8, 2017 and Mar 6, 2026 — classified as 80 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (11 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 85 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND INSTABILITY IN THE RIGHT KNEE. BOTH THE LATERAL COLLATERAL LIGAMENT (LCL) AND MEDIAL COLLATERAL LIGAMENT (MCL) HAD BEEN SURGICALLY REPAIRED PREVIOUSLY. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24532612 ↗
• InjuryFeb 17, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSE FEMORAL AND TIBIAL COMPONENT. FEMUR AND TIBIAL TRAY WERE LOOSE AT CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24364868 ↗
• InjuryFeb 5, 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 24272285 ↗
• MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED, WHICH COMPROMISED THE SEALING OF THE IMPLANT. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240311 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23770979 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO SURGEON IN CLINIC WITH KNEE STIFFNESS AND WAS UNABLE TO GET KNEE INTO FULL EXTENSION. SURGEON PERFORMED FULL REVISION OF PRIMARY ATTUNE IMPLANTS TO ATTUNE REVISION WITH SLEEVES ON BOTH SIDES (TIBIA AND FEMUR).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 22965806 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RESECTION FOR INFECTION, I&D POLY EXCHANGE PERFORMED (B)(6) 2025. THE PATIENT CONTINUED TO HAVE WOUND PROBLEMS AND DRAINAGE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22842780 ↗
• InjuryJul 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE ATTUNE PRIMARY KNEE REQUIRED REVISION DUE TO LOOSENING AND PAIN.

  Patient problems: Pain

  MAUDE report 22556262 ↗
• MalfunctionJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  STUDY NO: (B)(6) . CLINICAL ADVERSE EVENT RECEIVED FOR SLIDING & LOUD POPPING OF PATELLA/KNEE DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 08 AUG 2022, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OTHER - SPECIFY: QUAD EXERCISES.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22480808 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND EXPERIENCED A PERI PROSTHETIC DISTAL FEMUR FRACTURE. TOTAL KNEE WAS PERFORMED AS EXPECTED PRIOR TO THIS FALL; IMPLANTS HAD TO REMOVED TO CONVERT TO DISTAL FEMORAL REPLACEMENT. NO ALLEGATION IS MADE AGAINST ANY COMPONENTS. NO PATIENT HARM NOR DELAY WERE NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22384754 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. DOCTOR SAID CT SHOWED THAT THE FEMORAL COMPONENT WAS LOOSE. THE SURGEON CHECKED THE FEMORAL AND TIBIAL COMPONENTS BUT BOTH SEEMED TO BE STABLE. HE DECIDED TO REMOVE THE FEMORAL COMP THINKING IT MIGHT BE INFECTED. HE SENT CULTURES AND EVERYTHING WAS CLEAR FOR INFECTION. HE REPLACED THE FEMORAL WITH A CRS IMPLANT WITH SLEEVE AND STEM. THE APPROPRIATE SIZE POLY FOR RANGE OF MOTION WAS IMPLANTED. TIME WAS NOT EXTENDED IN SURGERY AND NOTHING WAS MENTIONED ABOUT BEING LOOSE OR A PROBLEM WITH OUR IMPLANTS. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21925815 ↗
• MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS SOME SORT OF DEBRIS FOUND INSIDE OF THE STERILE PACKAGING OF THE IMPLANT. A DIFFERENT IMPLANT WAS USED. THIS IMPLANT NEVER MADE IT ON TO THE FIELD AND ITS STERILE PACKAGING WAS NEVER BROKEN. THERE WAS NO SURGICAL DELAY. THERE WAS NOT ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872003 ↗
• InjuryJan 22, 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 PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21209221 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A UTI ROUGHLY ONE MONTH AGO, AND THE SURGEON BELIEVES IT SEEDED HER TOTAL KNEE AS THE PATIENT HAD BEEN DOING QUITE WELL PRIOR TO THIS EVENT. ALL WELL FIXED, WELL ALIGNED AND WELL FUNCTIONING IMPLANTS WERE REMOVED AND REVISED IN A ONE STAGE REVISION KNEE FOR INFECTION. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21149599 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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); Joint Laxity; Pain

  MAUDE report 20622087 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT ON (B)(6) 2024. THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA OA FOR BOTH KNEE JOINT WITH THE IMPLANT IN QUESTION. ON (B)(6) 2024, THE PATIENT COMPLAINED OF PAIN ON THE RIGHT SIDE. WHICH WAS EXAMINED AND FOUND TO BE INFECTED. THEREFORE, THE RIGHT IMPLANTS WERE REMOVED ON (B)(6). AND THE AFFECTED AREA WAS CLEANED. THE SURGEON DIAGNOSED IT, AS CEMENT MOLD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19722433 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FEMUR FRACTURE. THE EVENT WAS SERIOUS HOWEVER DEVICE AND PROCEDURE RELATEDNESS WERE NOT STATED. DATE OF EVENT: NOT INDICATED. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: NOT INDICATED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NOT INDICATED.

  Patient problems: Limb Fracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710464 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO, THERE WAS NO DELAY.

  Patient problems: Pain

  MAUDE report 19539567 ↗
• InjuryMay 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT AND TIBIAL BASE WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 19251936 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18915333 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING PATELLA AND CEMENT X 2. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SECONDARY TO DISCOMFORT, FALLS, JOINT INSTABILITY, AND A POSITIVE BONE SCAN WITH SUSPECTED TIBIAL LOOSENING. INTRAOPERATIVELY, HYPERTROPHIC SYNOVIAL AND GRANULATION TISSUE WAS IDENTIFIED. LOOSENING AT THE IMPLANT TO CEMENT INTERFACE WAS CONFIRMED. (B)(6) 2015 DOI . (B)(6) 2023 DOR (RIGHT KNEE).

  Patient problems: Discomfort; Fall; Joint Laxity; Synovitis

  MAUDE report 18894585 ↗
• InjuryFeb 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? - NO B. PLEASE CLARIFY WHICH COMPONENTS ARE LOOSE. - FEMUR/TIBIA.

  Patient problems: Insufficient Information

  MAUDE report 18763288 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. REMOVED IMPLANTS AND ANTIBIOTIC SPACER USED. DOI: UNK. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18432734 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MID FLEXION INSTABILITY. POLY WAS REVISED AND UPSIZED ON DEC 8, 2022. THE PATIENT STILL FELT UNSTABLE IN FLEXION AFTER UPSIZING. REASON FOR THE SURGERY WAS TO REMOVE COMPONENTS AND ADDRESS THE FLEXION OR EXTENSION MISMATCH. DOI: (B)(6), 2021. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 18247748 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S KNEE WAS UNSTABLE AFTER SHE FELL SO THE DOCTOR REVISED THE TIBIA, INSERT AND FEMUR COMPONENTS. DOI:(B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 17316896 ↗