ATTUNE 1506-80-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295492207), received between Feb 22, 2019 and Nov 26, 2025 — classified as 49 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (11 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23654052 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. SURGEON DECIDED TO TAKE OUT THE IMPLANTS AND REPLACE WITH A CEMENT SPACER. NO ISSUES WERE REPORTED WITH IMPLANTS. DOI: UNKNOWN DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22890385 ↗
• InjuryJul 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS PRESENT IN CLINIC. THE SURGEON WAS SUSPECTING ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON HAS SCHEDULED FOR REVISION SURGERY. LOOSENING INTERFACE: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22644187 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS A STAGE 1 KNEE REVISION. SURGEON TOOK OUT ALL COMPONENTS AND PUT IN AN ANTIBIOTIC SPACER TO RULE OUT INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22522496 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REMOVAL PROCEDURE DUE TO KNEE INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22005735 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BELIEVED THAT HE WAS EXPERIENCING AN ALLERGIC REACTION TO THE COCR IMPLANTS. SURGEON WAS NOT CONVINCED THAT THE PATIENT HAS AN ALLERGY TO NICKEL BUT DECIDED TO EXPLORE THE JOINT FOR LOOSENING, AND IF NO LOOSENING WAS FOUND, TO REVISE THE TKA USING OXINIUM AND TITANIUM IMPLANTS. CEMENT MANUFACTURER WAS COMPETITOR. A TWO-HOUR COMPLETE REVISION WAS PERFORMED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21934601 ↗
• InjuryApr 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE TIBIA WAS VERY LOOSE (CAME OUT BY HAND). FEMUR WAS SOMEWHAT FIXED, BUT INFECTION WAS FOUND INTRA-OP AND ALL COMPONENTS WERE REMOVED AND REPLACED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21927637 ↗
• InjuryJan 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY THE PATIENT THAT THE PATIENT HAD TOTAL KNEE REVISION RIGHT DUE TO PROSTHETIC THAT DID NOT ADHERE. THIS PROSTHETIC WAS CEMENTED AND DID NOT ADHERE. PATIENT HAD 3RD SURGERY IN 2024 THAT CAUSED LOTS OF PAIN, MISSED WORK, 3RD SURGERY.

  Patient problems: Pain

  MAUDE report 21263681 ↗
• InjuryJan 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT TKR RIGHT DUE TO PROSTHETIC THAT DID NOT ADHERE, THIS PROSTHETIC WAS CEMENTED AND DID NOT ADHERE, HAD 3RD SURGERY (B)(6) 2024. THIS CAUSED LOTS OF PAIN, MISSED WORK, 3RD SURGERY AND HIRING EXTRA CREW.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21157843 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HIS KNEE WAS NOT GETTING ENOUGH FLEXION OR FULL EXTENSION. SURGEON REMOVED THE TIBIA, RESECTED MORE PROX TIBIA AND REIMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20521525 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHRONIC DRAINAGE FROM KNEE AND SCHEDULED FOR IRRIGATION AND DEBRIDEMENT (I&D) WITH HARDWARE REMOVAL ON (B)(6) 2024. DOI: (B)(6) 2024. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 19992154 ↗
• InjuryMay 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISE DUE TO AESEPTIC LOOSENING OF THE PATELLA, TIBIA AND FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. FULL ATTUNE CRS WAS RE-IMPLANTED, THERE WAS NO X-RAYS AVAILABLE AT THIS TIME, IMPLANTS NOT BEING RETURNED. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19219915 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS PRESENTED WITH INFECTION AND INSTABILITY DUE TO LOOSENING OF THE PATELLA AND FEMORAL COMPONENTS AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ALL IMPLANTS WERE REVISED. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 18979980 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: - NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18836389 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY IS DELAYED PENDING BONE SCAN RESULTS , HAS NOT BEEN RESCHEDULED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 18776740 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18543379 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFLAMMATION AND KNOWN INFECTION. TEMPORARY SPACER WAS PUT IN FOR STAGE ONE INFECTION. NO LOOSENING AND NO SURGICAL DELAY WAS THERE. DOI: (B)(6), 2020. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 17825507 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STARTUP PAIN. TIBIA REVISION WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17754994 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ATTUNE CR RP CONSTRUCT DONE DUE TO LOOSENING AND INFECTION. THE SURGEON SAID THAT THE PATIENT EXPERIENCED PAIN FROM EARLY ON AFTER THE SURGERY SO SAID THEY PROBABLY GOT THE INFECTION FROM THE START. IMPLANTS WERE LOOSE AT THE CEMENT/BONE INTERFACE. SIMPLEX CEMENT WAS USED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17324492 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPICIOUS PERIPROSTHETIC INFECTION. TWO FEMORAL INTERFERENCE SCREWS IMPLANTED IN PREVIOUS ACL RECONSTRUCTION SURGERY WERE ALSO REMOVED. THE REPORT CONCERNS THE ENTIRE IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 16984974 ↗
• InjuryMay 10, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16902558 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16682920 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. FEMUR, TIBIA & INSERT ALONG WITH DEPUY BONE CEMENT WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 16610514 ↗
• InjuryMar 9, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ATTUNE CEMENTED TIBIA LOSENING RIGHT FIRST IMPLANTATION 2020 IN (B)(6). DOI: 2020, DOR: (B)(6) 2023, RIGHT KNEE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511890 ↗
• InjuryFeb 1, 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. ANTIBIOTIC SPACER WAS IMPLANTED. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16276825 ↗