ATTUNE 1518-20-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 10603295056676), received between Nov 20, 2017 and Jul 2, 2026 — classified as 132 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 140 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FLEXION CONTRACTURE WITH THINNEST POLY. REVISED FEMORAL COMPONENT TO OPEN EXTENSION GAP. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Septic loosening

  MAUDE report 25692101 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE FB TIB BASE SZ 4 CEM, ATTUNE PS FB INSRT SZ 5 6MM, ATTUNE PS FEM LT SZ 5 NAR CEM, ATTUNE MEDIAL DOME PAT 32MM, AND SMARTSET MV 40G - EO WERE INVOLVED IN A REPORTED EVENT. THE EVENT INVOLVED REVISION SURGERY OF A LEFT KNEE ARTHROPLASTY DUE TO LOOSENING OF THE ATTUNE TIBIAL BASEPLATE AND OTHER COMPONENTS, RESULTING IN SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY, DIFFICULTY AMBULATING, OSTEOLYSIS, INFLAMMATION, SYNOVITIS, EDEMA, AND JOINT INSTABILITY. THE PATIENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICE WAS REPLACED/REVISED. THE IMPLANT STATUS FOR THE INVOLVED DEVICES IS EXPLANTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Inflammation; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 24843825 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD FEMALE PATIENT RECEIVED A LEFT KNEE MUA WITH CERCLAGE REMOVAL 8 MONTHS POST LEFT KNEE REVISION WITH A FEMORAL FRACTURE COMPLICATION TO TREAT PAIN, STIFFNESS, AND ARTHROFIBROSIS. THE UNKNOWN CERCLAGE WIRE WAS REMOVED AS THE FRACTURE HAD HEALED. SCAR TISSUE WAS DEBRIDED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2022 ((B)(4) 1ST REVISION). DOE: (B)(6) 2022 ((B)(4) FEMORAL CRACK). DOE: (B)(6) 2023 (MUA WITH CERCLAGE REMOVAL). LEFT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain

  MAUDE report 24818721 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SURGEON SUSPICION OF INFECTION. NO OTHER INFORMATION IS KNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24691264 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT RECEIVED A PRIMARY LEFT KNEE ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2024, THE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS CONFIRMED TO BE LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. TIBIAL BONE OSTEOLYSIS WAS CURETTED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE PATELLA WAS WELL FIXED AND RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 24484502 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327412 ↗
• InjuryFeb 2, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT PATELLOFEMORAL ARTHRITIS REMOVAL FOR RIGHT PATELLOFEMORAL ARTHRITIS ON RIGHT KNEE WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2026, THE PATIENT COMPLAINED OF PAIN IN THE RIGHT PATELLA AND A CLUNKING SOUND IN THE PATELLA WHEN FLEXED. ON (B)(6) 2026, THE SECOND SURGERY WAS PERFORMED. THE SOFT TISSUE INSIDE THE PATELLA WAS REMOVED. THE SURGERY WAS COMPLETED WITHOUT REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 24241080 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT KNEE WAS INFECTED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24099111 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT OVER TIME, THE PATIENT'S KNEE BECAME PAINFUL AND TIBIA APPEARS TO HAVE SUBSIDED MILDLY. REVISION SURGERY WAS PERFORMED ON THE TIBIA, POLY, AND PATELLA, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23831681 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPLEX PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2025 USING A PRIMARY ATTUNE PS FEMUR, ATTUNE PS ROTATING PLATFORM INSERT, ATTUNE REVISION ROTATING PLATFORM TIBIAL TRAY WITH ATTUNE REVISION TIBIAL SLEEVE AND ATTUNE REVISION PRESSFIT STEM. THE PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE THAT HAD BEEN REPAIRED USING PLATES AND SCREWS, WHICH HAD SUBSEQUENTLY BEEN REMOVED PRIOR TO THE TOTAL KNEE REPLACEMENT SURGERY. AT THE TIME OF THE TKR SURGERY, NO CONCERNS WERE NOTED. POST-SURGERY, THE PATIENT'S MEDIAL COLLATERAL LIGAMENT APPEARS TO HAVE FAILED (THIS OCCURRED 2 DAYS POST-OPERATION ON ((B)(6) 2025), RESULTING IN THE KNEE BEING IN SEVERE VALGUS AND X-RAY INDICATING THAT THE POLY INSERT WAS NOW ROTATED OUT OF ITS INITIAL POSITION. THE KNEE WAS SUBSEQUENTLY PLACED IN A RANGE OF MOTION BRACE AND FOLLOW-UP X-RAYS SHOWED THE KNEE TO BE IN GOOD ALIGNMENT IN BOTH THE AP AND LATERAL VIEWS. AT THIS STAGE, NO FURTHER ACTION IS PLANNED BUT THE PATIENT WILL BE REVIEWED IN A COUPLE OF WEEKS.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 22895563 ↗
• InjuryJul 8, 2025Naturally Worn; Naturally Worn

  ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2025, THE PATIENT HAD A LEFT TOTAL REVISION TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT WITH DEBONDING OF THE CEMENT, MEDICAL POLYETHYLENE WEAR WITH SOME OSTEOLYSIS, MILD MID FLEXION INSTABILITY WITH EXTERNAL ROTATION OF THE FEMORAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE PAIN. DOI: (B)(6) 2016, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 22440783 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A TKA SURGERY FOR OA FOLLOWING A TIBIAL FRACTURE. THE SALESPERSON WAS INFORMED THAT A SYNOVECTOMY WAS PERFORMED ON (B)(6) 2025, UNDER ARTHROSCOPIC OBSERVATION USING A PATELLA CRANK. THERE WAS A LOT OF SYNOVIAL PROLIFERATION, SO IT WAS DIRECTLY REMOVED IN AN OPEN PROCEDURE. THE REMOVAL SURGERY WAS PERFORMED DUE TO LIMITED RANGE OF MOTION AND THE PATIENT'S PAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED THE FOLLOWINGS. - THE RELATIVELY DISTAL MOVEMENT OF THE JOINT SURFACE AND THE OBSERVED SWELLING OF THE PATELLAR TENDON MAY HAVE BEEN A FACTOR. - IT IS RECOGNIZED THAT A CERTAIN NUMBER OF PS SUFFER FROM PATELLA CRANK SYNDROME, REGARDLESS OF THE MODEL. IN THIS CASE, CRS FEMUR WAS USED, AND THE BOX RETIO WAS SLIGHTLY HIGHER THAN THE PS.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22418378 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO REMAIN INFECTED. SURGEON ELECTED TO REMOVE SOME COMPONENTS AND FUSE THE KNEE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22027322 ↗
• InjuryApr 29, 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. UNKNOWN SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21926090 ↗
• InjuryApr 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 FOR INFECTION. DOI: (B)(6) 2025 DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21738203 ↗
• MalfunctionJan 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE CIRCULATING NURSE OPENED THE STERILE PACKAGE, THE SURGICAL TECH NOTICED A HAIR INSIDE THE STERILE PACKAGING. THE IMPLANT WAS DISCARDED AND NOT USED. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114821 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR IT BAND TENDINITIS. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 26/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 151820032, LOT ID: 3802592, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT 32MM; CATALOG ID: 151820308, LOT ID: JP9042, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 3 8MM; CATALOG ID: 150400103, LOT ID: 8093073, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE C/RET FEM LT SZ 3 CEMENTED; CATALOG ID: 150670003, LOT ID: 9854210, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 3; CATALOG ID: 249095000, LOT ID: M0476R, COMPONENT TYPE: PIN, DESCRIPTION: AMK FIXATION PINS 1/8 DIA X 3; CATALOG ID: 950502303, LOT ID: M1312Z, COMPONENT TYPE: ACC, DESCRIPTION: SIGMA LCS HIGH PERFORMANCE, STERILE THREADED HEADED PINS; CATALOG ID: 3312040, LOT ID: 3807417, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20904071 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REMOVED DUE TO INFECTION. A SPACER WAS PLACED UTILIZING LPS COMPONENTS IN A DUAL SET UP FASHION IN CONJUNCTION WITH A THOROUGH I&D WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY NOR PATIENT HARM TOOK PLACE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS AT THIS TIME, AS ALL WERE WELL FIXED AND WELL FUNCTIONING. FEMORAL SIDE HAD BEEN REVISED ON (B)(6) 2023 AND AGAIN ON (B)(6) 2024. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20426558 ↗
• InjuryAug 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT REPORTED PATELLAR CLUNK. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20014235 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE REINFECTED AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED, AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT; THEY WERE SIMPLY REMOVED DUE TO INFECTION. CEMENT WAS HOSPITAL-OWNED, SO LOT INFORMATION WAS UNAVAILABLE, BUT THE SURGEON'S ROUTINE INVOLVED USING DEPUY 2 WITH GENT FOR REVISION CASES. ALL PART AND LOT INFORMATION WAS COPIED AND PASTED DIRECTLY FROM OPTIMIZE AND WAS ACCURATE PER THAT SYSTEM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928229 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE: BLANK ALERT DATE: 28-JUN-2019 COUNTRY OF EVENT: OUS PROCEDURE: TYPE OF REVISION - OPERATIVE DETAILS PART 1: FULL PROCEDURE: KNEE REVISION USING ATTUNE - OPERATIVE DETAILS PART 2: PS RP OPERATIVE SIDE: LEFT DATE OF SURGERY: (B)(6) 2019 EVENT DESCRIPTION (DIAGNOSIS): OPERATIVE WOUND DEHISCED CENTRAL 8CMS: FURTHER REVISION SURGERY REQUIRED UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR OPERATIVE WOUND DEHISCED CENTRAL 8CMS: WOUND DEHISCENCE REQUIRING DAIR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2019 DATE OF EVENT: 26 JUN 2019 (LEFT KNEE) TREATMENT: IRRIGATION & DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19645863 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS ACCUSING PAIN.

  Patient problems: Pain

  MAUDE report 19586314 ↗
• InjuryJun 14, 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 PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19539601 ↗
• InjuryMay 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT COMPLAINS OF PAIN AND HAS AUDIBLE PATELLA CREPITUS POST DISTAL FEMORAL REPLACEMENT. SIGNIFICANT TISSUE WAS EXCISED SURROUNDING THE PATELLA AND PATELLAR IMPLANT FOUND TO BE LOOSE. PATELLA WAS REPREPARED AND IMPLANTED SUCCESSFULLY WITH NO DELAY NOR PATIENT HARM. CEMENT WAS LIKELY DEPUY 2 WITH GENT BUT RECORDS ARE NOT AVAILABLE AS THE HOSPITAL'S INVENTORY WAS USED AT THIS FACILITY AND NOT PRESENT ON OUR RECORDS. DOI: (B)(6) 2022. DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 19381421 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 30, 2024, THE SALES REP WAS INFORMED THAT THE IMPLANT WAS SCHEDULED TO BE REMOVED DUE TO INFECTION. HE ALSO RECEIVED A REQUEST TO ARRANGE FOR A SET OF EXTRACTION INSTRUMENTS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2017. DOE: PENDING.

  Patient problems: Unspecified Infection

  MAUDE report 19310791 ↗