ATTUNE 1504-10-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10603295041764), received between Sep 5, 2017 and Aug 4, 2026 — classified as 119 injuries, 6 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 125 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to wound never healing. Put in static spacer.Affected side: Right knee.

  Patient problems: Impaired Healing

  MAUDE report 50126792 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FRACTURE OF RIGHT KNEE BEHIND THE FEMUR IMPLANT. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24496447 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ATTUNE PRIMARY WAS PUT IN A VALGUS KNEE. TRACKING WELL ON TABLE BUT SUBLUXES WHEN PATIENT FLEXES. LATERAL SIDE AND PATELLA FINE, MEDIAL SIDE - TIBIA MOVES ANTERIOR, FEMUR POSTERIOR. BEARING LOOKS SEATED ON XR, SIZES APPROPRIATE, NO LOOSE BODIES SEEN. IF WENT TO REVISION COULD I USE MEDIAL PIVOT BEARING IN THE PRIMARY TIBIA WITH PS FEMUR. ELDERLY LOW DEMAND PATIENT. NO REVISION SURGERY PLANNED.

  Patient problems: Joint Laxity

  MAUDE report 24443236 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROPLASTY INFLAMMATORY REACTION TO METAL DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY RELATED. PROCEDURE RELATED: POSSIBLY RELATED. DATE OF EVENT: 13 DEC 2018. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RESULTED IN A MEDICAL OR SURGICAL INTERVENTION, SURGICAL TREATMENT OF STUDY KNEE (DATE: (B)(6) 2019), COMPONENTS REMOVED (FEMORAL COMPONENT; TIBIAL BASE).

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 23928970 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE AND UPSIZED OF FEMORAL COMPARTMENT AND LARGER INSERT. NO PRODUCT PROBLEM WAS REPORTED. DOI: (B)(6) 2022, DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Joint Laxity

  MAUDE report 23513603 ↗
• MalfunctionOct 31, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THE PACKAGING OF THE ATTUNE FEMUR IMPLANT DID NOT HAVE THE STICKER TAG THAT ENABLES EASY REMOVAL FROM THE OUTER PACKAGING INTO THE STERILE FIELD. THE IMPLANT WAS TIPPED INTO THE STERILE FIELD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT CONSEQUENCES REPORTED. DOI: (B)(6) 2025 AFFECTED SIDE: RIGHT FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435174 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A KNEE REVISION DUE TO INSTABILITY. DOI: ON (B)(6) 2016, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23084759 ↗
• MalfunctionSep 17, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING TKR NURSE OPENED DEFINITIVE FEMUR AND NOTED THAT THE PACKAGING WAS WARPED. SURGEON WAS NOTIFIED AND WAS NOT CONFIDENT ABOUT THE STERILITY OF THE PRODUCT. ANOTHER IMPLANT OF THE SAME SIZE WAS AVAILABLE AND OPENED TO USE. THE SURGERY WAS DELAYED BY A 1 MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075414 ↗
• InjuryJul 17, 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 INFECTION. IMPLANTS WERE REMOVED, THERE WAS LOOSENING OF THE TIBIAL TRAY AT CEMENT TO THE IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22530092 ↗
• InjuryMay 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 LOOSE COMPONENTS FROM CHRONIC INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22063351 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ATTUNE RIGHT IMPLANTED ON (B)(6) 2024 IS HAVING INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 21448169 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO SURGERY FOR AN INFECTED KNEE. ALL KNEE IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. THERE WERE NO DELAYS OR BROKEN INSTRUMENTS. THE KNEE IS INFECTED BUT WAS NOT LOOSE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21420339 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR INSTABILITY. NO HARM TO PATIENT. NO DELAYS. NO BROKEN INSTRUMENTS. DOI- (B)(6) 2019; DOR- (B)(6) 2024; AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21113196 ↗
• InjuryOct 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024, DUE TO FEMORAL AND TIBIAL LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 20400630 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR KNEE PAIN. BONESCAN SHOWED THE RIGHT FEMORAL COMPONENT WAS LOOSE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. ADDITIONAL EVENT INFORMATION. THERE WAS LOOSENING AT THE CEMENT-BONE INTERFACE OF THE FEMUR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 20343901 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RUPTURED THE PATELLA TENDON. SURGEON REPAIRED THE PATELLA TENDON, THEN REMOVED AND REPLACED THE TIBIAL INSERT WITH A NEW IMPLANT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 20226061 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR: SEPTIC SHOCK. DEVICE AND PROCEDURE (RELATEDNESS): NO INFORMATION PROVIDED. DATE OF EVENT: 04-NOV-2021. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT KNEE. TREATMENT/IMPACT: REQUIRES INPATIENT HOSPITALIZATION/RESOLVED WITH RESIDUAL EFFECTS.

  Patient problems: Septic Shock

  MAUDE report 20124734 ↗
• InjuryJul 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION REPORTED DUE TO FEMUR MOBILIZATION.

  Patient problems: Pain

  MAUDE report 19741069 ↗
• 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 19584894 ↗
• InjuryMay 14, 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 19312480 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 18615379 ↗
• InjuryJan 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A RIGHT FEMUR WAS IMPLANTED ON A LEFT KNEE, THEN REMOVED FOR THE CORRECT SIDED PROSTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 18448013 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND LOOSENING OF FEMUR AT BONE TO CEMENT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18357385 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18284529 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18020998 ↗