ATTUNE 1504-40-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295042198), received between Nov 26, 2018 and Feb 17, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN & INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24367403 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 29 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS)

  Patient problems: Unspecified Infection

  MAUDE report 24200717 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR NO INFORMATION PROVIDED. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE OEDEMA. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: DEFINITELY. TREATMENT/IMPACT: OTHER (DRAINAGE) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440106 LOT NUMBER: J0841J COMPONENT TYPE: FEMORAL COMPONENT DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 LEFT CEMENTED. CATALOG NUMBER: 150640004 LOT NUMBER: 9640684 COMPONENT TYPE: TIBIAL BASE COMPONENT DESCRIPTION: ATTUNE REVISION TIBIAL BASE FIXED BEARING SIZE 4 CEMENTED. CATALOG NUMBER: 151700608 LOT NUMBER: H80128 COMPONENT TYPE: TIBIAL INSERT COMPONENT DESCRIPTION: ATTUNE REVISION CRS FIXED BEARING INSERT SIZE 6 8 MM. CATALOG NUMBER: 66017750 LOT NUMBER: 95654956 COMPONENT TYPE: CEMENT DESCRIPTION: HERAEUS MEDICAL GMBH PALACOS CEMENT. CATALOG NUMBER: 66017750 LOT NUMBER: 95904875 COMPONENT TYPE: CEMENT DESCRIPTION: HERAEUS MEDICAL GMBH PALACOS CEMENT.

  Patient problems: Swelling/ Edema

  MAUDE report 24151048 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT HOME AFTER SURGERY AND FELL, RESULTING IN A PERI-PROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23958294 ↗
• InjuryApr 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO NON-CEMENTED LOOSENING OF THE FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21925350 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT WAS REVISED DUE TO INFECTION. AN ARTICULATING SPACER AND ANTIBIOTICS WERE PLACED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21763743 ↗
• InjuryJan 13, 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 THE PAINFUL TKA. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21139454 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20352505 ↗
• InjuryMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL LOOSENING OF THE STUDY KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: 30 AUG 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL DISTAL AUGMENT, FEMORAL POSTERIOR AUGMENT, AND TIBIAL INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18835918 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD A REVISION AND ALL WENT WELL. THE IMPLANT LOOKED GOOD, AND NO SPECIAL SIGNS WERE VISIBLE. THE IMPLANTS WENT OFF TO HOSPITAL AARAU FOR SONIFICATION AND ARE NOT AVAILABLE ANYMORE. THE PATIENT DID GET A CEMENT SPACER AS A TEMPORARY REPLACEMENT INCLUDING ANTIBIOTIC TREATMENT AND WILL GET A NEW IMPLANT SOON. AT THE MOMENT IT WILL BE AN IMPLANT FROM A DIFFERENT PROVIDER.

  Patient problems: Unspecified Infection

  MAUDE report 18413885 ↗
• InjuryOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PATIENT PRESENTED FOR REVISION OF UNI COMPARTMENTAL TO TOTAL KNEE ARTHROPLASTY. PRIOR TO IMPLANTATION OF IMPLANTS ALL IMPLANTS WHERE VERIFIED WITH OPERATING SURGEON, CIRCULATING NURSE AND SALES REPRESENTATIVE. IMPLANTS WHERE IMPLANTED AFTER BEING DELIVERED TO FIELD BY CIRCULATING NURSE. UPON INVESTIGATION OF REPRESENTATIVE BILLING SHEET, PRIOR TO PLACING TIBIAL INSERT, SALES REP DISCOVERED THAT THE FEMORAL IMPLANT WAS NOT FOR THE CORRECT SIDE. OPERATIVE SIDE AS (RIGHT) IMPLANT USED WAS (LEFT). SURGEON WAS NOTIFIED IMMEDIATELY, AND FEMORAL COMPONENT WAS SURGICALLY REMOVED. CORRECT IMPLANTS WHERE THEN PRESENTED TO THE SURGICAL FIELD AND IMPLANTED AT THIS TIME. THERE WAS NO HARM TO PATIENT. SURGICAL TIME WAS EXTENDED DUE TO REMOVAL OF FEMORAL IMPLANT. ALL EVENTS OCCURRED INTRAOPERATIVELY BEFORE PATIENT LEFT THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961929 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION OF AN UNKNOWN ORIGIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17153578 ↗
• InjuryJan 24, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT PRESENTED TO HOSPITAL WITH INFECTION IN HIS LEFT TOTAL KNEE JOINT REPLACEMENT, THIS WAS A REVISION CONSTRUCT WHICH HAD BEEN IMPLANTED IN (B)(6) 2019. THE PRIMARY JOINT WAS A COMPETITOR IMPLANT. WORTH NOTING THAT THE PATIENT HAD A FALL IN 2020 WHICH RESULTED IN A PERIPROSTHETIC FRACTURE IN HIS TIBIA. THE FRACTURE WAS REDUCED AND FIXED WITH SCREWS AND A PLATE. THE SURGEON SUSPECTS THAT THIS IS THE ORIGIN OF THE INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 16233421 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATTUNE REVISION REMOVAL DUE TO A POST OPERATIVE FIXED FLEXION DEFORMITY FROM THE THE ORIGINAL REVISION SURGERY ON THE (B)(6) 2021 WITH A FOLLOWING SURGERY FOR A POLY REVISION ALSO DONE ON (B)(6) 2022 TO SEE IF WE DOWNSIZED THE POLY AND IF THAT WOULD HELP THE DEFORMITY. PATIENT WAS VERY UNHAPPY (ALSO NOT A COMPLIANT PATIENT WITH POST OPERATIVE RECOVERY).

  Patient problems: Loss of Range of Motion

  MAUDE report 15994874 ↗
• InjuryDec 5, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  3RD REVISION. ATTUNE REVISION FEMUR LOSENING.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15914258 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION, ATTUNE SPACER PUT IN ITS PLACE. IMPLANTS RETAINED BY HOSPITAL. NO OTHER CONSEQUENCES TO PATIENT. PRIMARY SURGERY DATE IS UNKNOWN, FIRST REVISION SURGERY DATE (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15874109 ↗
• InjuryNov 4, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 15737115 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MEDICAL RECORDS FROM (B)(6) 2022 NOTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION COMPLETED ON (B)(6) 2022. AFTER THE REVISION, THE PATIENT HAD ERYTHEMA OVER THE INCISION AND A STITCH ABSCESS WAS CUT OUT. PATIENT REPORTS HAVING PAIN DUE TO THE SUPERFICIAL INFECTION". NOTE: THE PATELLA WAS LEFT IN SITU DURING (B)(6) 2022 REVISION.

  Patient problems: Abscess; Erythema; Pain; Unspecified Infection

  MAUDE report 15257781 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2021. (LEFT KNEE) TREATMENT: INJECTED MEDICATION; DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 15197910 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REVISED THE PATIENT DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND PUT IN A TEMPORARY ANTIBIOTIC KNEE SPACER. THERE WAS NO LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14159756 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. SURGEON CONVERTED FEMUR TO HINGE FEMUR. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13900509 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PHYSICAL THERAPY NOTES AND PROGRESS NOTES (B)(6) 2021 INDICATE THE PATIENT FELT UNWELL AND LIGHTHEADED MULTIPLE TIMES WITH ONE BRIEF LOSS OF CONSCIOUSNESS DUE TO ORTHOSTATIC HYPOTENSION POST REVISION PROCEDURE ¿ TREATED WITH BOLUS OF 500 ML NORMAL SALINE PER EPISODE.

  Patient problems: Dizziness; Low Blood Pressure/ Hypotension

  MAUDE report 12895499 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY: DSJ-2016-02 NEW. AN ADVERSE EVENT HAS BEEN GENERATED. PLEASE REVIEW THIS EVENT AS SOON AS POSSIBLE. EVENT DETAILS EVENT DATE: (B)(6) 2021. ALERT DATE: (B)(4) 2021. COUNTRY OF EVENT: (B)(4). 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: 29 JUN 2018 EVENT DESCRIPTION (DIAGNOSIS): PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE PATIENT DETAILS: PATIENT IDENTIFIER: (B)(4). GENDER: MALE AGE (AT TIME OF CONSENT): (B)(6). HEIGHT: (B)(6). WEIGHT: (B)(6). ADDITIONAL PATIENT DETAILS: DATE OF EVALUATION: (B)(6) 2021. SITE AWARENESS DATE: (B)(6) 2021. EVENT TYPE: NEW EVENT. IF WORSENING EVENT, PLEASE SPECIFY LOG LINE: BLANK DID THIS EVENT OCCUR AT THE OPERATIVE SITE ?: YES IN THE OPINION OF THE INVESTIGATOR, WAS THIS ADVERSE EVENT EXPECTED/ANTICIPATED?: NO IS THIS A SERIOUS ADVERSE EVENT? IF YES, SELECT ALL THAT APPLY: NO. DEATH: NO. LIFE-THREATENING: NO. HOSPITALIZATION (INITIAL OR PROLONGED): NO DISABILITY OR PERMANENT DAMAGE: NO CONGENITAL ANOMALY OR BIRTH DEFECT: NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: NO WAS T

  Patient problems: Synovitis

  MAUDE report 12786718 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL UPDATE RECEIVED. THE DATABASE IDENTIFIES PHYSICAL THERAPY AS A TREATMENT TO ADDRESS KNEE PAIN.

  Patient problems: Pain

  MAUDE report 12711604 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: ARTHROSCOPY OF RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11633546 ↗