ATTUNE 1504-40-206Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295042297), received between Oct 2, 2018 and Apr 20, 2026 — classified as 50 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE WHEN WALKING AND REQUIRED REVISION SURGERY DUE TO LOOSENING OF IMPLANTS. THE REVISION PROCEDURE WAS PERFORMED TO ADDRESS PAIN AND IMPLANT LOOSENING AT AN UNKNOWN INTERFACE, AND ALL AFFECTED IMPLANTS WERE EXPLANTED AND DISCARDED. PATIENT HAD 3 PREVIOUS REVISIONS ON THIS KNEE.

  Patient problems: Pain

  MAUDE report 24927568 ↗
• InjuryNov 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL KNEE REVISION DONE BY THE DOCTOR AT THE HOSPITAL (B)(6) 2020. FEMUR BECAME LOOSE AND PATIENT WAS BROUGHT IN BY THE HOSPITAL FOR A FEMUR REVISION. FEMORAL COMPONENTS AND RP REVISION INSERT WERE REMOVED. THE RP REVISION TIBIA WAS NOT LOOSE AND STAYED IMPLANTED. NO COMPLICATIONS OR DELAYS IN SURGERY DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23633754 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607461 ↗
• InjuryNov 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO ARTHROFIBROSIS AND LOOSE FEMUR. NON-ARTICULAR SURFACE OF FEMORAL COMPONENT SHOWED ABUNDANT CEMENT REMAINING. UNKNOWN CEMENT MANUFACTURER.

  Patient problems: Adhesion(s)

  MAUDE report 23463826 ↗
• InjurySep 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE SLEEVE, STEM, AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. REMOVED ALL FEMUR IMPLANTS AND DID NEW. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23016892 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE. THE PATIENT HAS HAD MILD PAIN SINCE THIS TIME. RECENT ASPIRATION WAS POSITIVE FOR INFECTION WHICH COULD HAVE BEEN PRESENT SINCE THE TIME OF REVISION. A ONE STAGE REVISION WAS PERFORMED AS THE ORGANISM IS SENSITIVE. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED AND THE KNEE WAS WELL BALANCED. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. NEW COMPONENTS, ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. NO DELAYS NOR PATIENT HARM WAS NOTED. SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR REVISION KNEE REPLACEMENTS. CEMENT IS HAND MIXED IN A BOWL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22792033 ↗
• InjuryJul 21, 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 INFECTED RIGHT KNEE. SPACER PLACEMENT WAS DONE. NO SURGICAL DELAY WAS REPORTED. AFFECTED SITE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22556557 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR INFECTION OF RIGHT REVISION TOTAL KNEE. THE KNEE WAS VERY INFECTED, AND ALL OF THE COMPONENTS CAME OUT WITH MINIMAL EFFORT. NO SPECIFIC COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22113264 ↗
• MalfunctionApr 28, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE TRIAL FEMUR WENT DOWN FINE, BUT WHEN THEY TRIED TO IMPLANT THE REAL, IT WOULD NOT SIT. TRIED MULTIPLE TIMES. LATER OPENED A NEW FEMUR WITH THE SAME STEM AND IT WENT DOWN FINE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921471 ↗
• InjuryFeb 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO FEMUR BEING LOOSE. THE LOOSENING INTERFACE WAS CEMENT BONE INTERFACE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21472333 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENTS RECEIVED FOR FOLLOWING A PERIOD OF EXTENDED CROUCHING, HAS EXPERIENCED A TENDER POINT MID RIGHT SHIN AND A PAINFUL RIGHT KNEE; DEVICE AND PROCEDURE(RELATEDNESS), RELATEDNESS TO DEVICE: POSSIBLY, RELATEDNESS TO PROCEDURE: POSSIBLY. DATE OF EVENT: OCT 2023, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21295809 ↗
• InjuryNov 25, 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 A TKA FOR KNEE OA. DURING TEMPORAL REDUCTION, IT DID NOT EXTEND FULLY. WHEN THE SURGEON SLIGHTLY PUSHED THE HIP JOINT TO EXTEND, A FRACTURE OCCURRED AT THE FEMUR. THEREFORE, PINNING WAS PERFORMED TO FIX THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SURGEON GUESSED THAT THE EVENT OCCURRED BECAUSE OF POOR BONE QUALITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 20771060 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20589029 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR POSITIVE TISSUE BIOPSY X2 KNEE SYNOVIUM: DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 15 JAN 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20507058 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE TO A FRACTURED FEMUR POST INITIAL SURGERY. THE ORIGINAL IMPLANT SURGERY WAS AN UNKNOWN DATE IN 2020. THERE WAS NO SURGICAL DELAY AND NO ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20303074 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND UNSTABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20279643 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN ATTUNE REV KNEE CONSTRUCT WAS IN. IT WAS REVISED WITH A SINGLE STAGE REIMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20145234 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY. FEMORAL COMPONENT AND POLY WERE REMOVED AND REPLACED WITH LPS COMPONENTS. THERE WAS NO LOSS OF CASE TIME. DOI: (B)(6) 2021. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19567698 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AFTER THE PATELLA TENDON RUPTURE. NO DELAY PATELLA IS AN IMPLANT AND NOT REMOVED. INSTABILITY NOT RELATED TO POLY WEAR. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18981173 ↗
• InjuryMar 14, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AT THE UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6), 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18903049 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: 1. THE PATIENT FELL AND NEEDED LARGER COMPONENTS. 2. NO REPORTED SURGICAL DELAYS.

  Patient problems: Fall; Pain

  MAUDE report 18893615 ↗
• MalfunctionMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR CLUNK. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: ON (B)(6) 2023 DATE OF EVENT: 27 FEB 2024 (RIGHT KNEE) TREATMENT: OBSERVATION.

  Patient problems: Insufficient Information

  MAUDE report 18892874 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR TENDER POINT MID RIGHT SHIN AND PAINFUL RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: UNK OCT 2023. (RIGHT KNEE) . TREATMENT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 18825476 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A PERIPROSTHETIC FEMUR FRACTURE. FRACTURE JUST ABOVE THE CEMENTED STEM. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Limb Fracture

  MAUDE report 18364182 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTED KNEE POST REVISION TOTAL KNEE ARTHROPLASTY. ALL COMPONENTS WERE WELL ALIGNED, WELL FIXED AND APPROPRIATELY SIZED BUT WERE REMOVED DUE TO INFECTION. A ONE STAGE DUAL SET UP REVISION WAS PERFORMED WITH THOROUGH DEBRIDEMENT AND IRRIGATION AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM OCCURRED. THERE WERE TWO DATES OF IMPLANTATION AS THE PATELLAR COMPONENT WAS RETAINED FROM THE PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022. ALL OTHER COMPONENTS LISTED WERE PLACED (B)(6) 2023. THE CEMENT UTILIZED WAS HOSPITAL INVENTORY AND AS SUCH WAS NOT AVAILABLE IN THE RECORDS. DOI: (B)(6) 2022 (PATELLAR COMPONENT), DOI: (B)(6) 2023 (ALL OTHER COMPONENTS), DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18302556 ↗