ATTUNE 1517-10-816Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295056287), received between Dec 7, 2020 and Nov 4, 2025 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS THE REASON FOR THE REVISION WAS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23469784 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL CONSTRUCT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT ONE STAGE REVISION DONE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23390067 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP FOR POSSIBLE INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22386489 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20181365 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POLY SWAPPED DUE TO P ACNES INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18300517 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND OPENED INCISION, GOING IN WITH A POLY EXCHANGE. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Pocket Erosion

  MAUDE report 17964383 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D OF KNEE WITH POLY SWAP WAS PERFORMED FOR SUSPECTED INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15983657 ↗
• InjuryJun 3, 2022Adverse 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 SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2022, (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 14597999 ↗
• InjuryMay 10, 2022Adverse 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 SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 14345455 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO INFECTION IN THE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2021. (LEFT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13118980 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE BECAUSE THE KNEE HAD NO MOTION DUE TO EXCESSIVE SCAR TISSUE. NO ADDITIONAL INFORMATION. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

  Patient problems: Scar Tissue

  MAUDE report 12634017 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A POLY SWAP AND AN I&D WERE PERFORMED. DOI: (B)(6) 2019, DOR: (B)(6) 2021,LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11796747 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH THE INCISION. POLY WAS EXTRACTED TO HELP AID IN SCAR TISSUE REMOVAL. A NEW POLY WAS OPENED AND IMPLANTED. NO ISSUES WITH IMPLANTS. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 10958696 ↗