ATTUNE 1504-10-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10603295041658), received between Dec 22, 2017 and Sep 23, 2026 — classified as 103 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (19 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 113 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 ATTUNE PS FEM LT SZ 8 CEM, ATTUNE PS FB INSRT SZ 8 5MM, and ATTUNE FB TIB BASE SZ 7 CEM were involved in a left knee total knee arthroplasty revision case. The patient was reportedly unable to rehabilitate the knee after surgery and had very limited motion of 15 to 40 degrees. Revision surgery was performed to address the condition. During the procedure, all components were described as well fixed and well aligned, and no allegation was made against any of the components. A difficult exposure was performed with tissue elevation and removal of scarring. All well-fixed components were removed, and the revision total knee arthroplasty was completed without delay or patient harm. Range of motion was reported to be quite good, and a good outcome was expected. The cement was described as likely DePuy 2, hand mixed in an open bowl per surgeon protocol. The implanted devices were explanted.Affected Side: Left Knee.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 50868727 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY WERE PLANNING ON DOING A POLY EXCHANGE DUE TO INFECTION BUT FOUND OUT THE TIBIA WAS LOOSE SO REMOVED FEMUR/TIBIA & POLY. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25110857 ↗
• InjuryMar 31, 2026Noise, Audible

  IT WAS REPORTED THAT THE PATIENT RECEIVED A LEFT ATTUNE TKA FOR UNKNOWN REASONS. DEPUY CEMENT X1 WAS UTILIZED AND THE PATELLA WAS RESURFACED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, WALKING DIFFICULTY, JOINT INSTABILITY, AUDIBLE POPPING SOUNDS, EMOTIONAL DISTRESS, AND ANXIETY. UPON ENTERING THE JOINT, SCAR TISSUE WAS DEBRIDED. THE SURGEON IDENTIFIED A LOOSENED TIBIAL TRAY AT THE DEPUY CEMENT TO IMPLANT INTERFACE, WHICH WAS REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2023. DOR: (B)(6) 2024. LEFT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Distress; Joint Laxity; Pain

  MAUDE report 24744620 ↗
• InjuryFeb 10, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING COMPONENTS AT THE CEMENT IMPLANT INTERFACE. CEMENT MANUFACTURER: UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24306879 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN . DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24177913 ↗
• InjuryDec 24, 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: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23888124 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COULD NOT ACHIEVE FULL FLEXION. SURGEON REMOVED THE OLD FEMORAL COMPONENT AND SWAPPED IT FOR A FEMORAL COMPONENT A SIZE SMALLER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23789604 ↗
• InjuryDec 5, 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 PERSISTENT PAIN LEFT KNEE. PATIENT HAD RETAINED HARDWARE FROM PRIOR ACL SURGERY. BONE SCAN SHOWED SOME UPTAKE ON BOTH FEMUR AND TIBIA COMPONENTS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23729739 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: DOI (B)(6) 2017: MALE PATIENT RECEIVED A LEFT DEPUY ATTUNE PRIMARY KNEE TO TREAT SEVERE DJD. THE PATELLA WAS NOT RESURFACED, AND THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED WITH DEPUY SMARTSET CEMENT X2. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PART/LOT INFORMATION IS PROVIDED ON PP.5-6. DOR (B)(6) 2022: 58-YEAR-OLD MALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT CHRONIC PAIN, INSTABILITY, AND WALKING DIFFICULTY SECONDARY TO FEMORAL OSTEOLYSIS AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED FEMORAL OSTEOLYSIS AND ABUNDANT FEMORAL OSTEOPHYTES. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. FEMORAL OSTEOLYSIS WAS CURETTED WHEN THE FEMORAL COMPONENT WAS REMOVED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE POSTOPERATIVE SWELLING AND VENOUS DOPPLER NOTED ON (B)(6) 2022 WAS RELATED TO THE COMPETITOR KNEE AND NOT ASSOCIATED WITH A DEPUY DEVICE OR PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 23540953 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A FIRST STAGE KNEE REVISION ON (B)(6) 2025, DUE TO INFECTION. THE COMPONENTS REMOVED THAT DAY WERE NOT DEPUY. ORIGINAL SURGERY DATE IS UNKNOWN. THE TWO IMPLANTS REMOVED ON (B)(6) 2025, WERE REMOVED TO PREFORM A SECOND STAGE REVISION. NO LOOSENING, NO CEMENT FAILURE, NO PATIENT CONSEQUENCE, NO SURGICAL DELAY. DOI: (B)(6) 2025 DOR: (B)(6), 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22555216 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN THE TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED BY THE SURGEON. THERE WAS NO DELAYS IN SURGERY OR ANY PATIENT INJURY. DOI: (B)(6), 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22496754 ↗
• InjuryJul 10, 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. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22468140 ↗
• MalfunctionMay 26, 2025Device Markings/Labelling Problem; Wrong Label; Device Markings/Labelling Problem; Wrong Label

  IT WAS REPORTED THAT THE SIZE 8 LEFT PS FEMORAL IMPLANT DID NOT HAVE THE SIZE/LATERALITY OF THE COMPONENT WRITTEN ON THE INSIDE OF THE IMPLANT. THE FEMORAL COMPONENT SHOULD HAVE A MARKING TO VERIFY THE SIZE/LATERALITY, BUT THIS IMPLANT DID NOT HAVE IT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084028 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REMOVAL PROCEDURE DUE TO KNEE INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22005738 ↗
• InjuryMar 4, 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 TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURE WAS DEPUY. THERE WAS ALSO INFECTION IN KNEE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21514471 ↗
• MalfunctionJan 7, 2025Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping; Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE IMPLANT WAS OPENED TO FIND THAT THE INNER CONTAINER WAS NOT SEALED. THERE WAS NO GLUE ON RIM OF INNER CONTAINER AND NO PAPER LID. DUE TO PACKAGING ERROR, STERILITY OF IMPLANT QUESTIONED AND DEEMED NOT SAFE FOR IMPLANTATION INTO PATIENT.

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

  MAUDE report 21091367 ↗
• InjuryNov 27, 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 LATERAL KNEE PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20794868 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN ATTUNE PRIMARY LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS ON (B)(6) 2016. DEPUY BONE CEMENT WAS USED. AS PART OF THE TREATMENT, PATIENT ALSO RECEIVED AUTOLOGOUS PLATELET RICH PLASMA WHICH WAS APPLIED TO THE DEEP PORTIONS OF THE PATIENT'S INCISION DURING WOUND CLOSURE TO SUPPORT WOUND HEALING. THE PATIENT HAD NO COMPLICATIONS. PATIENT'S LEFT TOTAL KNEE WAS REVISED ON (B)(6) 2024, TO ADDRESS ASEPTIC IMPLANT LOOSENING OF THE TIBIAL BASEPLATE WITH COMPLETE DEBONDING (CEMENT TO IMPLANT INTERFACE) AND CHRONIC PATELLAR TENDON RUPTURE. FEMUR, TIBIAL BASEPLATE, AND INSERT WERE EXPLANTED. PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. PATELLA TENDON WAS REINFORCED WITH A TUBULARIZED MARLEX MESH BUNDLE. THERE WERE NO COMPLICATIONS. COMPETITOR REVISION FEMUR AND TIBIAL COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2016. DOR: (B)(6) 2024. LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20658527 ↗
• InjuryJul 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT REQUIRE REVISION SURGERY DUE TO PAIN ASSOCIATED WITH ASEPTIC LOOSENING OF ATTUNE TIBIA PLATEAU.

  Patient problems: Pain

  MAUDE report 19656798 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVED IMPLANTS AND PLACED TEMPORARY SPACER. NO ADDITIONAL DETAILS AVAILABLE. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19599742 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL ATTUNE KNEE DONE. THE PATIENT WAS INFECTED, SO ALL COMPONENTS WERE REMOVED AND TEMPORARY PARTS IMPLANTED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19593224 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR UNKNOWN PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO OTHER INFORMATION. DOI- (B)(6) 2022, DOR- (B)(6) 2024 , AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19564199 ↗
• InjuryApr 8, 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 WAS REVISED DUE TO INFECTION. THE SPACER WAS REPLACED FOR INFECTED KNEE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19061590 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS KNEE WAS INFECTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18836311 ↗
• MalfunctionFeb 20, 2024Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON NOTICED SCRATCHES AND A FOREIGN SUBSTANCE ON THE SURFACE OF A SZ 8 PS LEFT FEMUR. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738984 ↗