ATTUNE 1504-40-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295042280), received between Mar 27, 2018 and Aug 7, 2026 — classified as 52 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 16, 2018Class IITerminated

   There may be burrs on the extraction hole threads.

   Z-1704-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Degraded

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. 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 infection. Femoral component shows moderate corrosion.

  Patient problems: Unspecified Infection

  MAUDE report 50178237 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24747456 ↗
• 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 24327403 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054086 ↗
• InjuryJan 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF AN ATTUNE DUE TO LOOSE FEMORAL AND TIBIAL COMPONENTS. THE SURGEON NOTED FIBROUS TISSUE UP THE FEMORAL CANAL AROUND THE FEMORAL STEM CAUSING LOOSENING. THE TIBIAL COMPONENT WAS LOOSE AS IT APPEARED THAT THE SURGEON HAD CEMENTED IN THE CEMENTLESS TIBIAL SLEEVE. RESULTING IN NO BONE INGROWTH. THE PATELLA COMPONENT WAS RETAINED FROM PREVIOUS PRIMARY TKR. THE LOOSENING WAS BETWEEN THE IMPLANT AND BONE INTERFACES. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fibrosis

  MAUDE report 23958201 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CRS FEMORAL RT SZ 5 CEM, ATUNE PRESSFIT STR STEM12X60MM, ATTUNE CEMENTED STEM 14X50MM, ATTUNE CRS RP INSRT SZ 5 6MM, ATUNE REV RP TIB BASE SZ 4 CEM, ATUN TIB SLV M/L 29MM HALF POR, AND ATTUNE MEDIAL ANAT PAT 32MM WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A REVISION OF A PREVIOUS ATTUNE REVISION PROCEDURE, WITH THE REASON FOR REVISION BEING INFECTION. THE SURGEON SUSPECTED INFECTION AT THE TIME OF IMPLANTATION DUE TO POOR INGROWTH IN THE TIBIAL SLEEVE AND NOTED THAT THE CEMENTED FEMORAL STEM WAS EASILY REMOVED. THE EVENT WAS ASSOCIATED WITH THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23862733 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526884 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022 A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF. PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING TO MAKE KNEE MOVE. DR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE. DR. HAS REQUESTED TO HAVE THE ATTUNE REV HINGE SYSTEM SO DR. DOES NOT HAVE TO REMOVE THE WELL-FIXED SLEEVE IN THE FEMUR. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE PATIENT STIFFNESS WHICH WAS OCCURRED AFTER THE 1ST REVISION SURGERY WHILE RELATED COMPLAINT (B)(4) REPORTS THE 1ST REVISION SURGERY WHICH OCCURRED IN (B)(6) 2022.

  Patient problems: Muscular Rigidity

  MAUDE report 23011423 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22852513 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY, A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI. FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM, THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TORNIQUET WAS REMOVED AND THE LEG MOVED POST OP. THE PATIENT WAS TRANSFERRED TO HAVE PLATING COMPLETED TO REPAIR THIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 22703129 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS HAD FIVE PRIOR KNEE REVISION PROCEDURES ON THIS KNEE. DURING THIS PROCEDURE, THE PATIENT'S REVISION COMPONENTS WERE REMOVED DUE TO INFECTION. A STATIC SPACE, MADE OF ANTIBIOTIC BONE CEMENT AND STEINMANN PINS, WERE IMPLANTED TO SPAN THE PATIENT'S KNEE UNTIL HER INFECTION HAS CLEARED. THERE WAS NO SURGERY TIME EXTENDED. DOI: (B)(6) 2023 (FEMORAL COMPONENTS) AND (B)(6) 2024 (TIBIAL COMPONENTS). DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21610612 ↗
• InjuryMar 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21549867 ↗
• InjuryFeb 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A RIGHT KNEE COMPLETE SECOND REVISION WAS PERFORMED DUE TO FEMORAL AND TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. PATIENT EXPERIENCED PAIN AND REQUIRED HARDWARE REMOVAL DUE TO LOOSENING. CEMENT NOT FROM DEPUY.

  Patient problems: Pain

  MAUDE report 21409621 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. LOOSENING INTERFACE WAS MENTIONED AS NOT APPLICABLE. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: (B)(6) 2018 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21232726 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PERIPROSTHETIC FRACTURE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 20559012 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 22 NOV 2018. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461526 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FROM NEXGEN TO ATTUNE REVISION ON (B)(6) 2020. HAS PRESENTED WITH INSTABILITY AND X-RAY SHOWS THE TIBIA HAS SUBSIDED. CONCERNED WITH INTEGRITY OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS THE PATIENT HAS HAD KNEE REVISED ONCE AGAIN FOR A HINGE.

  Patient problems: Joint Laxity

  MAUDE report 20051661 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION OF STUDY JOINT, HOSPITALIZATION AND ATTUNE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 19701936 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING OF RIGHT SHIN PAIN LEADING TO POLY EXCHANGE AND PATELLAR RESURFACING. TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION, REVISION OF STUDY JOINT.

  Patient problems: Pain

  MAUDE report 19345956 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 18713124 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION RIGHT KNEE. POLY SUBLUXATION. CONVERSION TO HINGE KNEE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6),2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17661265 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT REVISION FOR INSTABILITY. PATIENT'S PRIMARY WAS WITH COMPETITOR PRODUCTS ON A UNKNOWN DATE. PATIENT HAD FIRST REVISION (REASON UNKNOWN) ON (B)(6) 22, WHERE OUR PRODUCTS WERE IMPLANTED. PATIENT HAD 2ND REVISION ON THE (B)(6) 22 FOR INSTABILITY, (B)(4). THEN A 3RD REVISION FOR INSTABILTY, THIS PC, ON THE (B)(6) 23.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037687 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DISTAL FEMORAL REPLACEMENT DUE TO PRIOR INFECTION AND SOFT TISSUES STRETCHING EXTENSIVELY RESULTING IN THE DISLOCATION OF THE HINGED COMPONENT WITH THE LARGEST AVAILABLE POLY. THE DISTAL FEMORAL COMPONENT WITH A POROUS STEM WAS LOOSE AND REMOVED EASILY. THE DISTAL FEMORAL COMPONENT WAS REVISED TO A CEMENTED STEM AND A THICK MBT TRAY WAS IMPLANTED WITH A 21MM POLY. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN SIDE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 16933681 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REVISION PROCEDURE IN (B)(6) 2022 AT A DIFFERENT HOSPITAL, PATIENT PRESENTED WITH EVIDENCE OF INFECTION OF HER KNEE JOINT REPLACEMENT AND HAD A DAIR PROCEDURE TO ATTEMPT TO ELIMINATE THE INFECTION ALONG WITH ANTIBIOTIC COVER. THIS UNFORTUNATELY WAS UNSUCCESSFUL AND THE DECISION WAS MADE TO REMOVE ALL IMPLANTS AND REPLACE WITH A TEMPORARY TIBIAL NAIL WHICH BRIDGES ACROSS THE KNEE JOINT WITH ANTIBIOTIC LOADED CEMENT. THE PATIENT WILL RETURN IN 6-8 WEEKS FOR PLANNED KNEE REVISION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 16875567 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RIGHT KNEE WAS REVISED DUE TO INFECTION. A MOBILE SPACER WAS PLACED AND ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16761434 ↗