ATTUNE 1504-00-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10603295041207), received between Aug 9, 2017 and Sep 23, 2026 — classified as 58 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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 59 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implant removed due to infection. No patient consequence. No surgical delay.Affected side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50867440 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CASE HAD BEEN REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24875187 ↗
• InjuryApr 13, 2026Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: KINDLY SPECIFY THE ADVERSE EVENT ON THE PATIENT? LOOSENING OF THE FEMUR IMPLANT. CAN YOU PERHAPS TELL ME WHAT IS THE SIGNIFICANCE OF VELYS IN THE EVENT DESCRIPTION AND WHY THIS IS BEING SPECIFIED? THERE IS NO SPECIAL SIGNIFICANCE OF VELYS, THE ONLY THING WAS, THAT ALL THE PATIENTS WITH A FEMORAL DEBONDING WERE VELYS CASES. WE DID NOT EXPERIENCE (OR WAS NOT REPORTED) THIS DEBONDING SITUATIONS IN CONVENTIONAL CASES. BUT THERE IS NO PROOF THAT VELYS IS CAUSALLY RELATED TO FEMORAL DEBONDING.

  Patient problems: Insufficient Information

  MAUDE report 24863371 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REPLACEMENTS SURGERY IN 2024 ON BOTH KNEES. FOLLOWING THE KNEE BILATERAL REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED A SERIES OF ADVERSE EVENTS INCLUDING INFECTION, WOUND DEHISCENCE, BLEEDING, ALLERGIC REACTION TO NICKEL, FOREIGN BODY REACTION, LOSS OF RANGE OF MOTION, KNEE SWELLING, NIGHT SWEATS, SCAR TISSUE FORMATION, AND TWO FALLS. THE INFECTION REQUIRED INTRAVENOUS ANTIBIOTICS, AND ALLERGY TESTING CONFIRMED SENSITIVITY TO NICKEL. THE PATIENT CONTINUES TO EXPERIENCE SIGNIFICANT PAIN AND HAS A REVISION PLANNED FOR THE RIGHT KNEE, WITH NO PLANS FOR THE LEFT KNEE AT THIS TIME. THE IMPLANT REMAINS IN SITU.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Distress; Fall; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24517835 ↗
• InjuryOct 16, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. POST-OPERATIVELY WHILE REVIEWING THE USAGE REPORT SHEET, IT WAS NOTICED THAT A RIGHT KNEE PROSTHESIS WAS USED INSTEAD OF A LEFT KNEE PROSTHESIS. NO INTERVENTION WAS REQUIRED AT THE TIME OF THE INCIDENT, BUT THERE IS A POTENTIAL REQUIREMENT FOR REVISION SURGERY IN THE FUTURE.

  Patient problems: Insufficient Information

  MAUDE report 23312861 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED PRIMARY KNEE. COMPONENTS WERE REMOVED AND NEW IMPLANTS USED AS TEMPORARY SPACER. THERE WERE NO COMPLAINTS OR DELAYS. COMPONENTS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22338213 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REVISED DUE TO RECURRENT INFECTION. IMPLANT FAILURE WAS NOT IN QUESTION.

  Patient problems: Unspecified Infection

  MAUDE report 22170615 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS GROSSLY INFECTED. PATIENT FELL AND SPLIT OPEN KNEE. REMOVED ALL IMPLANTS. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 20844116 ↗
• InjuryAug 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 20077756 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR STIFF RIGHT TKA. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Muscular Rigidity

  MAUDE report 19645641 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WAS THERE ANY SURGICAL DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19213556 ↗
• InjuryJan 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. THERE WAS SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18464033 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION, ALL IMPLANTS WERE TAKEN OUT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17051902 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE REVISION FOR FEMORAL COMPONENT BEING IMPLANTED IN TO MUCH FLEXION IN 2016. COMPONENTS WERE REMOVED AND ATTUNE REVISION WAS PUT IN. PLEASE NOT THE PATELLA WAS LEFT IN SITU.

  Patient problems: Joint Laxity

  MAUDE report 16831492 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND WAS LOOSE IN EXTENSION AND WOULDN¿T BALANCE IN FLEXION. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 16808541 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO CHRONIC INFECTION. UPON VISUAL INSPECTION THERE WERE NO DEFICIENCIES. NONE OF IMPLANTS WERE BROKEN. THERE WAS NO TIME ADDITIONAL TIME ADDED TO THE CASE. IMPLANTS WERE PUT IN 2014. SALES REP DO NOT HAVE AN EXACT DATE. THERE WAS NO SURGICAL DELAY. DOI- 2014, DOR- (B)(6) 2023, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16426156 ↗
• InjuryJan 5, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ATTUNE TKR FEMORAL COMPONENT REVISED FOR LOOSENING. PATIENT HAD PAIN - BONE SCAN & X-RAY SHOWED FEMORAL LOOSENING. REVISED TO ATTUNE REVISION FEMORAL COMPONENT WITH STEM. ORIGINAL SURGERY ON (B)(6) 2018. REVISED ON (B)(6) 2022. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: NO. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY 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: Pain

  MAUDE report 16104433 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PER PROSTHETIC FRACTURE OF FEMUR DUE TO FALL. SYNTHES NAIL PLACED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15568799 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PRIMARY ATTUNE TKR ON THE (B)(6) 2022. DURING THE PRIMARY SURGERY THE FELLOW NICKED THE MCL BUT ELECTED TO CONTINUE WITH THE PLANNED IMPLANT CONSTRUCT AS IT WAS IN HIS OPINION A "MINOR NICK" AND THE KNEE FELT STABLE AND BALANCED AT TRIAL AND FINAL IMPLANTATION. THE PATIENT STARTED PARTIAL WEIGHT BEARING DURING STANDARD POST OP MOBILITY REHABILITATION, AND THE MCL BECAME MORE DEFICIENT AND THE CR RP INSERT DISLOCATED. THE PATIENT WAS BROUGHT BACK TODAY FOR A FULL REVISION TO AN ATTUNE CRS.

  Patient problems: Joint Laxity; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15502872 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A WELL ALIGNED TOTAL KNEE BUT HAD POOR MOTION, 20-95. A REVISION KNEE WAS PERFORMED AS EVEN WITH REMOVAL OF THE INSERT AND THOROUGH DEBRIDEMENT. FULL EXTENSION WAS NOT OBTAINED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 15129399 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FAILED RIGHT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE, EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: ON (B)(6) 2022, PATIENT'S RIGHT KNEE FEMUR, TIBIAL TRAY, AND TIBIAL INSERT COMPONENTS WERE REVISED; PATELLA COMPONENT WAS RETAINED.

  Patient problems: Insufficient Information

  MAUDE report 14453598 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOWER RESPIRATORY TRACT INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN, DATE OF EVENT (ONSET): (B)(6) 2022, (UNKNOWN KNEE). TREATMENT: UNSPECIFIED INJECTED AND ORAL MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 13422732 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ,CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE POST OPERATIVE PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN; DATE OF EVENT (ONSET): (B)(6) 2022; (UNKNOWN KNEE). TREATMENT: UNSPECIFIED INJECTED MEDICATION, UNSPECIFIED ORAL MEDICATION, AND FEMORAL NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 13415707 ↗
• InjurySep 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. UNKNOWN CEMENT MANUFACTURER. TIBIA SUBDIVIDED AND FEMUR SLOWED LOOSENING VIA X-RAY AND PATIENT PRESENTED TO SURGEON IN OFFICE. DOI: (B)(6) 2014, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12487543 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH PAIN AND INSTABILITY. SO SURGEON REMOVED ALL COMPONENTS AND REPLACED WITH ATTUNE REVISION TO IMPROVE STABILITY. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12167837 ↗